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392 Study Matches

MT2018-46: Longterm Follow-up of Subjects with Cerebral Adrenoleukodystrophy who were Treated with Lenti-D Drug Product

This is a multi-center, long-term safety and efficacy follow-up study for subjects with cerebral adrenoleukodystrophy (CALD) who have received Lenti-D Drug Product in parent clinical studies. Lenti-D Drug Product is defined as an autologous CD34+ cell-enriched population that contains cells transduced with Lenti-D lentiviral vector encoding the human adrenoleukodystrophy protein. In parent studies, male subjects with CALD are infused on a single occasion with Lenti-D Drug Product, and then followed for 24 (±1) month for safety and efficacy. The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) recommend long-term follow-up for subjects treated with gene therapy drug products to monitor for selected adverse events (AEs), as well as durability of clinical response. Therefore, after subjects have completed the parent clinical studies, they will be asked to participate in a long-term follow-up Study LTF-304, in which they will be followed every 6 months through 5 years post-drug product infusion, and then annually through 15 years post-drug product infusion. Safety evaluations will include documentation of drug product-related AEs, all serious adverse events (SAEs) regardless of attribution to the drug product, CALD-related ≥Grade 2 AEs, and integration site analysis for the detection of clonal dominance through 15 years post drug product infusion, as well as archiving for RCL testing through 5 years post‑drug product infusion. Efficacy evaluations will include CALD disease-specific assessments, primarily major functional disabilities and brain MRI, with additional exploratory assessments for change in Loes score, Loes pattern, neurologic function score (NFS), very long chain fatty acids (VLCFA), intelligence quotient (IQ), and health related quality of life (HRQoL) assessment. To monitor pharmacodynamics, vector copy number in peripheral blood (PB VCN; vector copies per diploid genome [c/dg]) and transgenic protein expression of adrenoleukodystrophy protein (ALDP) in peripheral blood will be measured at designated study visits. There is no designated Data Monitoring Committee (DMC) for Study LTF-304; however, the review of safety data for this study, including AEs, SAEs and relevant laboratory values, may be performed by the DMC convened for the parent study in which the subject(s) originally participated.

Paul Orchard
Male
Not specified
NA
This study is NOT accepting healthy volunteers
NCT02698579
STUDY00005330
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Inclusion Criteria:

• Provision of written informed consent for this study by the participant or participant's parent(s)/ legal guardian(s) and written informed assent by participant, if applicable
• Have received Lenti-D Drug Product in a parent clinical study
• Able to comply with study requirements
Exclusion Criteria:

• There are no exclusion criteria for this Study
Genetic: Lenti-D
Cerebral Adrenoleukodystrophy (CALD), Adrenoleukodystrophy (ALD), X-Linked Adrenoleukodystrophy (X-ALD)
Adrenoleukodystrophy, X-linked Adrenoleukodystrophy, Hematopoietic Stem Cells
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MT2019-01: Adrenoleukodystrophy National Registry Study (ALD) and Biobank

In this protocol, we will enroll pediatric, adolescent and adult patients diagnosed with adrenoleukodystrophy (ALD). These patients will include probands diagnosed by newborn screening and their relatives subsequently diagnosed, as well other patients who are diagnosed with ALD due to other presenting signs and symptoms and subsequently were confirmed to have ALD. We will ask consenting subjects to provide a medical history (with verification via medical records), to participate in a semi-annual health survey and provide consent to collect biospecimens. The overarching goal of this work is to engage with families affected by ALD and to assemble a resource of clinical, medical, and biological data that will allow of to better understand the natural history of ALD, and how this is affected by newborn screening. The initial focus will be on patients within Minnesota, but participation will be open to any family interested in the study, as this will be web-based. This registry and biobank, together with other research conducted in tandem, will possibly provide information describing the natural history of ALD and outcomes with interventions. It is anticipated that the data collected will further our understanding of the natural history of the disease, basic biology of adrenoleukodystrophy, diagnosis and outcomes. Ultimately, this research may lead to new avenues for early diagnosis and development of safer and more effective therapies for ALD.

Ashish Gupta
All
Not specified
NA
This study is NOT accepting healthy volunteers
NCT03789721
STUDY00003605
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Inclusion Criteria
• Age 0 - 100
• ALD patients or family member meeting any of the following criteria:
• Any patient diagnosed with ALD (confirmed by positive VLCFA testing and/or genetic mutation).
• Known or presumed mutation with ALD based on pedigree or confirmed mutation in ABCD1 gene
• Participants living in the United States and territories Exclusion Criteria
• Patients diagnosed with ALD who lack the capacity to consent/assent AND do not have a designated legally authorized representative or guardian.
• Patients who have undergone BMT or other cellular therapy .
• Patients not fluent in English who are unable to consent in-person at the BMT Journey Clinic.
• Patients who are illiterate
• Patient determined by the PI or designee to be unlikely to complete required study components (due to language barriers, compliance issues, etc.)
Other: Medical Record Abstraction, Other: Biospecimen Sample Collection
ALD (Adrenoleukodystrophy), Adrenoleukodystrophy, Cerebral Adrenoleukodystrophy
Registry, VLCFA, ABCD1, X-chromosome
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National Pediatric Cardiology Quality Improvement Collaborative (NPC-QIC) - A Collaborative Initiative to Improve Care of Children with Complex Congenital Heart Disease (NPC-QIC)

This study is a prospective, non-randomized, observational multi-center study, utilizing a quality improvement methodology to facilitate systematic care coordination, interstage cardiovascular monitoring, and nutritional monitoring into every day practice. Utilizes a national registry to document the impact of these changes on various care processes and outcomes. The aim of this Phase II project intends to: 1) develop and support a robust national registry to gather clinical care process, outcome and developmental data on infants with HLHS between diagnosis and the first year of life, 2) engage pediatric cardiology and cardiac surgery programs in using the registry, and 3) use data from the registry to support and monitor the implementation of QI strategies to standardize and improve care for these infants.

Kavisha Shah
All
up to 15 Months old
N/A
This study is NOT accepting healthy volunteers
NCT02852031
STUDY00004329
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Inclusion Criteria:

• Fetuses or newborns diagnosed with HLHS or other univentricular condition
• Intended to undergo Norwood procedure
Exclusion Criteria:

• None
Other: Collaborative Learning Network
Hypoplastic Left Heart Syndrome (HLHS)
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Pediatric Obesity Weight Evaluation Registry (POWER) Study (POWER)

All
up to 18 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02121132
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Inclusion Criteria:

• age 18 years or younger
• overweight or obese patient
• initial medical evaluation in a pediatric weight management program between March 1, 2014-April 30, 2020.
Exclusion Criteria:

• no exclusion criteria
Overweight, Obesity
Overweight, Obesity
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Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry

The primary objective for this observational study is to collect general and medical data from children, adolescents, and young adults who had pediatric onset rheumatic disease. This data will be used to evaluate the long-term safety and efficacy of therapeutic agents used to treat these diseases. This information will allow investigators to accurately report and follow changes in current medication use patterns and compare these to proposed standards and current treatment recommendations. The use of a single registry will allow for more analysis of the different therapeutic agents by allowing them to be compared to each other.

Colleen Correll
All
up to 21 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02418442
1506M74443
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Inclusion Criteria:

• Onset of rheumatic disease prior to age 16 years for JIA and onset prior to age 19 years for all other rheumatic diseases (see appendix A).
• Subject (and/or parent/legal guardian when required) is able to provide written informed consent and willing to comply with study procedures.
• Subject and/or parent/legal guardian is willing to be contacted in the future by study staff.
Exclusion Criteria:

• Greater than 21 years of age at the time of enrollment.
Rheumatic Joint Disease
Systemic Arthritis, Oligoarthritis, Polyarthritis (Rheumatoid Factor Negative), Polyarthritis (Rheumatoid Factor Positive), Psoriatic Arthritis, Enthesitis Related Arthritis (ERA), Undifferianted Arthritis, CARRA Consensus Treatment Plans
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The (IRAD) International Registry for Acute Aortic Dissection

The International Registry of Aortic Dissection (IRAD) was created in 1996 by cardiovascular specialists committed to expanding current knowledge of aortic dissection with the goal of improving patient outcomes. This registry study uses a standardized form to capture data from consecutive patients with aortic dissection at participating hospitals.

Andrew Shaffer
Clinical Outcomes Research
This study is NOT accepting healthy volunteers
NCT01552720
1111M06641
Aortic Dissection
aorta, dissection, feature
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The Organ Care System (OCS) Lung Thoracic Organ Perfusion (TOP) Post Approval Study (PAS) Registry - OCS Lung TOP PAS Registry (TOP)

To collect additional real-world safety and effectiveness data for the OCS™ Lung System and to expand the long-term clinical evidence supporting the use of OCS™Lung System in lung transplantation.

Stephen Huddleston
All
18 Years and over
NA
This study is NOT accepting healthy volunteers
NCT03639025
STUDY00003837
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This is an all-comers registry that will enroll all:
• Consented patients who receive OCS™ preserved double lung transplants from either standard criteria donors or donors initially deemed unacceptable; and
• Consented patients who receive a single lung transplant from OCS™ preserved lung pairs from either standard criteria donors or donors initially deemed unacceptable; and
• All donor lungs that were perfused on OCS Lung System. Enrolled patients will fall into one of the following three possible analysis categories:
• TOP SCDL PAS Primary Analysis Population: will be comprised of the first 289 eligible/PAS consented recipients transplanted with SCDL primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
• TOP DLIDU Primary Analysis Population: Will be comprised of the first 266 eligible/PAS consented recipients transplanted with DLIDU primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
• All Other Enrolled Patients: will be comprised of all OCS Lung transplanted patients in the TOP Registry that do not meet any of the above analysis populations.
Device: OCS Lung System
Lung Transplantation
Clinics and Surgery Center (CSC)
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University of Minnesota Transplant Registry

This registry is open for people of all ages who have either received or donated an organ at the University of Minnesota. This study aims to evaluate organ transplant outcomes among people who have been part of the transplant program.

All
Not specified
N/A
This study is NOT accepting healthy volunteers
NCT01062581
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Inclusion Criteria:

• Received a transplanted organ at the University of Minnesota
• Living donor who donates an organ at the University of Minnesota
Exclusion Criteria:

• Did not receive a transplant at the University of Minnesota
• Did not donate an organ at the University of Minnesota
Transplant Recipient, Transplant Donation
Recipient, Donor, Organ Transplant, Registry, University of Minnesota
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The REPLACE Registry

This is a prospective, observational, non-interventional patient registry designed to document product safety and clinical outcomes for 10 years in patients treated with Cholbam/Kolbam, including those who have been using Cholbam/Kolbam for at least one month (existing users) and those who start Cholbam/Kolbam treatment at enrollment (new users). Patients who have been using Cholbam/Kolbam for less than one month and those who had previously been treated and who restart treatment will also be included but will not be counted in the existing or new users groups.

Boris Sudel
All
Not specified
Post Market Monitoring
This study is NOT accepting healthy volunteers
NCT03115086
STUDY00003757
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Inclusion Criteria:

• Male and female patients, of any age.
• The patient and/or the patient's parent/legal guardian is willing and able to provide signed informed consent, and the patient, if less than 18 years of age, is willing to provide assent as appropriate and in accordance with local regulatory, IRB, and EC requirements.
• The patient has a diagnosis for which Cholbam is indicated.
• The patient is or will be treated with Cholbam at the time of signing the informed consent form (ICF) (enrollment).
Exclusion Criteria:

• Patients who, by judgement of the Investigator, will not be able to comply with the requirements of the protocol will be excluded
Drug: Cholbam
Bile Acid Synthesis Disorders
Bile Acid Synthesis Disorder, Zellweger Spectrum Disorder, Peroxisomal Disorder, Cholic Acid, Cholbam, The REPLACE Registry
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An Observational Registry of Abatacept in Patients with Juvenile Idiopathic Arthritis (BMS Protocol IM101240)

The objective of this study is to create an international registry with long-term follow-up to characterize and evaluate the safety of abatacept in juvenile idiopathic arthritis (JIA). The primary objective of the JIA registry is to describe the long-term safety of abatacept treatment for JIA by quantifying the incidence rates of serious infections, autoimmune disorders, and malignancies.

Colleen Correll
All
up to 17 Years old
N/A
This study is NOT accepting healthy volunteers
NCT01357668
1403M48721
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:

• Diagnosis of JIA (any subtype)
• Age < 18 years at the time of enrollment unless currently or previously enrolled in an abatacept clinical trial and received abatacept
• Receiving Abatacept at the time of enrollment as per treating physician's decision or received abatacept in a clinical trial
• Parent or legally acceptable representative willing to participate in the study and sign the informed consent
Exclusion Criteria:

• Pregnant or nursing female at the time of enrollment
• Prior malignancies if the patient has not been malignancy free for at least 5 years.
• Any serious acute or chronic medical condition other than JIA, including chronic infection, which would compromise the patient's ability to participate in the study
• Known poor compliance with clinic visits (based on physician judgment)
Juvenile Idiopathic Arthritis
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MT2013-31:Allogeneic Hematopoietic Cell Transplantation for Inherited Metabolic Disorders and Severe Osteopetrosis following Conditioning with Busulfan (Therapeutic Drug Monitoring), Fludarabine +/- ATG

To evaluate the ability to achieve high-level donor hematopoietic engraftment (defined as neutrophil recovery by Day +42 post-transplant and ≥ 80% donor cells on the myeloid fraction of peripheral blood at Day +100 post-transplant) using related and unrelated BM, PBSC, or UCB grafts following a reduced intensity conditioning regimen based on targeted-exposure busulfan, fludarabine +/- serotherapy in patients with inherited metabolic disorders and severe osteopetrosis.

Paul Orchard
All
up to 55 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT02171104
1406M51542
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Inclusion Criteria:

• 0 through 55 years of age
• Adequate graft available
• Adequate organ function
• Eligible Diseases:
• Mucopolysaccharidosis Disorders:
• MPS IH (Hurler syndrome)
• MPS II (Hunter syndrome) if the patient has no or minimal evidence of symptomatic neurologic disease but is expected to have a neurologic phenotype
• MPS VI (Maroteaux-Lamy syndrome)
• MPS VII (Sly syndrome)
• Glycoprotein Metabolic Disorders:
• Alpha mannosidosis
• Fucosidosis
• Aspartylglucosaminuria
• Sphingolipidoses and Recessive Leukodystrophies:
• Globoid cell leukodystrophy
• Metachromatic leukodystrophy
• Niemann-Pick B patients (sphingomyelin deficiency)
• Niemann-Pick C subtype 2
• Peroxisomal Disorders:
• Adrenoleukodystrophy with cerebral involvement
• Zellweger syndrome
• Neonatal Adrenoleukodystrophy
• Infantile Refsum disease
• Acyl-CoA-Oxidase Deficiency
• D-Bifunctional enzyme deficiency
• Multifunctional enzyme deficiency
• Alpha-methylacyl-CoA Racmase Deficiency (AMACRD)
• Mitochondrial Neurogastrointestingal Encephalopathy (MNGIE)
• Severe Osteopetrosis (OP)
• Hereditary Leukoencephalopathy with axonal spheroids (HDLS; CSF1R mutation)
• Other Inherited Metabolic Disorders (IMD): Patients will also be considered who have other life-threatening, rare lysosomal, peroxisomal or other similar inherited disorders characterized by white matter disease or other neurologic manifestations for which there is rationale that transplantation would be of benefit, such as certain patients with Wolman's disease, GM1 gangliosidosis, I-cell disease, Tay-Sachs disease, Sandhoff disease or others.
• Voluntary written consent
Exclusion Criteria:

• Pregnancy - menstruating females must have a negative serum or urine pregnancy test within 14 days of study treatment start
• Prior myeloablative chemotherapy exposure within 4 months of the start of conditioning on this protocol (patients excluded for this reason may be eligible for other institutional protocols)
• Uncontrolled bacterial, fungal or viral infections including HIV (including active infection with Aspergillus or other mold within 30 days)
Biological: Stem Cell Transplantation, Drug: IMD Preparative Regimen, Drug: Osteopetrosis Only Preparative Regimen, Drug: Osteopetrosis Haploidentical Only Preparative Regimen, Drug: cALD SR-A (Standard-Risk, Regimen A), Drug: cALD SR-B (Standard-Risk, Regimen B), Drug: cALD HR-D (High-Risk, Regimen C), Drug: cALD HR-D (High-Risk, Regimen D)
Mucopolysaccharidosis Disorders, Hurler Syndrome, Hunter Syndrome, Maroteaux Lamy Syndrome, Sly Syndrome, Alpha-Mannosidosis, Fucosidosis, Aspartylglucosaminuria, Glycoprotein Metabolic Disorders, Sphingolipidoses, Recessive Leukodystrophies, Globoid Cell Leukodystrophy, Metachromatic Leukodystrophy, Niemann-Pick B, Niemann-Pick C Subtype 2, Sphingomyelin Deficiency, Peroxisomal Disorders, Adrenoleukodystrophy With Cerebral Involvement, Zellweger Syndrome, Neonatal Adrenoleukodystrophy, Infantile Refsum Disease, Acyl-CoA Oxidase Deficiency, D-Bifunctional Enzyme Deficiency, Multifunctional Enzyme Deficiency, Alpha-methylacyl-CoA Racmase Deficiency, Mitochondrial Neurogastrointestingal Encephalopathy, Severe Osteopetrosis, Hereditary Leukoencephalopathy With Axonal Spheroids (HDLS, CSF1R Mutation), Inherited Metabolic Disorders
Clinics and Surgery Center (CSC), allogeneic hematopoietic cell transplantation, bone marrow transplantation, IMD, AMACRD, MNGIE, HDLS, OP, ALD
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Feasibility of a Yoga Intervention in Sedentary African-American Women

Female
18 Years to 65 Years old
N/A
This study is also accepting healthy volunteers
NCT04710979
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Inclusion Criteria:

• Self-identified as an African-American woman at least 18 years old
• Engaging in less than 30 minutes/week of moderate-to-vigorous physical activity
• If employed, working in a sedentary occupation that requires primarily seated work; • If unemployed, typical day involves sedentary, primarily seated activities
• Able to exercise for 20 minutes continuously
• No pre-existing condition that limits physical activity
• Access to a computer (or mobile device) and internet service
Exclusion Criteria:

• Diagnosed with heart disease, diabetes, cancer, kidney, liver disease, major depression or bipolar disease
• Take more than two daily medications for lipids or blood pressure
• Current smoker
Behavioral: Yoga Intervention
Sedentary Behavior
Yoga, African-American, Feasibility Study
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ELEVATE, a global observational longitudinal prospective registry of patients with acute hepatic porphyria (AHP)

This is a global, multicenter, prospective, observational, longitudinal registry conducted to characterize the natural history and real-world clinical management of patients diagnosed with AHP. This protocol will not recommend the use of any specific treatments, visits, or procedures. No medication is provided as part of registry participation.

Gregory Vercellotti
Post Approval
This study is NOT accepting healthy volunteers
NCT04883905
STUDY00012826
Acute Hepatic Porphyria
AHP, Acute hepatic porphyria, Clinics and Surgery Center (CSC), Givosiran
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Alport Syndrome Treatments and Outcomes Registry (ASTOR)

The Alport Syndrome Treatments and Outcomes Registry (ASTOR) was founded in 2007 with the goal of facilitating clinical trials of new treatments for the disease. Because Alport syndrome is a rare disorder, rapid recruitment of sufficient participants for meaningful therapeutic trials will be greatly enhanced by pre-existing patient registries.

All
up to 99 Years old
N/A
This study is NOT accepting healthy volunteers
NCT00481130
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Inclusion Criteria:
History of a diagnosis of Alport syndrome, Family or individuals need to be able to comprehend the consent and HIPAA forms written in the English language.
Exclusion Criteria:
Uncertain diagnosis of Alport syndrome.
Alport Syndrome
Alport Syndrome, x linked, autosomal dominant Alport syndrome, glomerular basement membrane, hereditary nephritis, familial benign haematuria, type IV collagen, hereditary nephritis with neurosensory deafness, vison loss
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DegenPRO: A multicenter prospective registry for the management of degenerative spine disorders

This is an observational registry database for adult patients diagnosed with degenerative spine disorders, which aims to add information to the understanding of the disease management of this spine diseases. By creating this registry, a more complete picture of degenerative spine disorders - including treatment practices - will be established, by collecting information about the health status of patients across several hospitals in several countries. Research of this kind will help future patients by providing doctors with information about degenerative spine disorders, and about patients' treatment outcomes. Data from this registry may be used to generate descriptive statistics on demographics, and clinical characteristics, including co-morbidities, treatment patterns and adverse outcomes (resulting from treatment or disease), as well as patients' quality of life measurements. Condition: Patients with a degenerative spine disorder Intervention/procedure investigated: No specific treatment required. Study design: Prospective case series

Christopher Martin
NA
This study is NOT accepting healthy volunteers
NCT02802033
STUDY00000102
Degenerative Diseases, Spinal Cord
Clinics and Surgery Center (CSC), Osteobiologics, Registry, Spinal Fusion, Spine
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Connect? MDS/AML Disease Registry

This is a prospective, longitudinal, multi-center observational cohort study of patients with newly diagnosed MDS, ICUS or AML within 60 days prior to the date of ICF signature. Each enrolled patient will be followed for 8 years, or until early study termination, patient withdrawal or death, whichever occurs first. This study is observational and all decisions regarding patient care will be made by the treating physician. Objectives of this study is to describe the current and evolving patterns for diagnosis, prognosis, treatment, clinical monitoring and outcome measures in patients with LR or HR MDS, ICUS and AML, to compare routine clinical practice patterns with existing management guidelines, to describe treatment patterns and outcomes in patients with or without additional cytogenetic abnormalities, and to summarize patient-reported HRQoL outcomes and economic outcomes and their associations with patient characteristics, treatment regimens and clinical outcomes.

Birendra Kumar
NA
This study is NOT accepting healthy volunteers
NCT01688011
1503M66501
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Primary Myelofibrosis
AML, Acute myeloid leukemia, Connect®, ICUS, Idiopathic Cytopenias of Undetermined Significance, MDS, MDS/MPN overlap syndromes, MF, Myelodysplastic syndromes, Myelodysplastic/Myeloproliferative overlap syndromes, Myelofibrosis, Registry
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Prospective Global Registry for the Study of Chronic Total Occlusion Intervention (PROGRESS-CTO)

All
Not specified
N/A
This study is NOT accepting healthy volunteers
NCT02061436
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Inclusion Criteria:

• Patients undergoing CTO PCI at each of the participating centers.
Exclusion Criteria:

• None
Coronary Artery Disease
chronic total occlusion, percutaneous coronary intervention
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Pulmonary Hypertension Association Registry (PHAR) (PHAR)

The PHAR is a multicenter, prospective registry of newly evaluated patients at PHCCs in the United States who have either PAH or CTEPH. The goals of the PHAR include 1) measuring and improving quality of care (including assessing differences in adherence to evidence-based guidelines and establishing benchmarks for health outcomes), 2) determining the clinical effectiveness, comparative effectiveness, and cost effectiveness of treatment approaches, 3) understanding risk factors for outcomes and regional/center differences, and 4) facilitating funded clinical trials of new therapies and collaboration with the PAH community at large, including providers, patients, and their caregivers.

Thenappan Thenappan
All
Not specified
Clinical Outcomes Research
This study is NOT accepting healthy volunteers
NCT04071327
1702M07281
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Inclusion Criteria:

• All age groups
• Written informed consent
• Pulmonary arterial hypertension (PAH), chronic thromboembolic pulmonary hypertension (CTEPH), or pediatric PH due to developmental lung disease
• Within 6 months of first outpatient visit at a PH Care Center
Exclusion Criteria:

• Diagnosis of WSPH Group 2 pulmonary hypertension
• Diagnosis of WSPH Group 3 pulmonary hypertension, except PH due to developmental lung disease
• Diagnosis of WSPH Group 5 pulmonary hypertension
Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Hypertension
Clinics and Surgery Center (CSC)
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Corrona Inflammatory Bowel Disease (IBD) Registry

This is a prospective, non-interventional, research study for patients with IBD under the care of a certified gastroenterologist. The primary objective for this registry is to prospectively study the natural history of IBD, the prevalence and incidence of comorbidities, targeted adverse events, and more, via questionnaires.

Byron Vaughn
NA
This study is NOT accepting healthy volunteers
NCT03162549
STUDY00007736
Inflammatory Bowel Diseases
Clinics and Surgery Center (CSC)
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Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) Registry (IPF/ILD-PRO)

Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) Registry is a prospective registry that will collect information regarding the natural history, health care interactions, participant reported questionnaire data to assess quality of life of IPF participants, and the methods of treatment of participants with a diagnosis of idiopathic pulmonary fibrosis (IPF) established at the enrolling centers. In addition, blood samples will be collected and banked for future research projects.

Hyun Kim
All
30 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT01915511
1408M52921
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Inclusion Criteria:

• Willing and able to provide informed consent
• Established a new diagnosis of IPF by the enrolling subspecialty center (as defined by ATS/ERS/JRS/ALAT criteria)
• Age 30 years or older, or
• Diagnosis of a non-IPF ILD of any duration, including, but not limited to Idiopathic Non-Specific Interstitial, Pneumonia (iNSIP), Unclassifiable Idiopathic Interstitial Pneumonias (IIPs), Interstitial Pneumonia with Autoimmune Features (IPAF), Autoimmune ILDs such as Rheumatoid Arthritis (RA-ILD) and Systemic Sclerosis (SSc-ILD), Chronic Hypersensitivity Pneumonitis (HP), Sarcoidosis or Exposure-related ILDs such as asbestosis with progressive phenotype
Exclusion Criteria:

• Malignancy, treated or untreated, other than skin or early stage prostate cancer, within the past 5 years
• Currently listed for lung transplantation at the time of enrollment
• Currently enrolled in a clinical trial at the time of enrollment in this registry
Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease
Idiopathic pulmonary fibrosis, Pulmonary fibrosis, IPF, Registry, 1199.174, Interstitial Lung Disease, ILD, Interstitial Lung Disease with Progressive Phenotype, Clinics and Surgery Center (CSC)
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ALX-HPP-501: An Observational,Longitudinal Prospective, Long-term Registry of Patients with Hypophosphatasia

This multinational, multicenter, observational, prospective, long-term registry is designed to collect data on epidemiology, HPP history, clinical course, symptoms (including multi-systemic aspects of disease), and burden of disease from patients of all ages who have a diagnosis of HPP. In addition, the Registry will collect data on asfotase alfa dosing, effectiveness of treatment, SAEs, immunogenicity, pregnancy and neonatal outcome data (for patients treated with asfotasealfa only), and targeted EOI.

Kyriakie Sarafoglou
NA
This study is NOT accepting healthy volunteers
NCT02306720
STUDY00004936
Hypophosphatasia (HPP)
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Pulmonary Fibrosis Foundation Patient Registry (PFFR) (PFFR)

The Pulmonary Fibrosis Foundation Patient Registry will collect data on at least 2,000 patients at approximately 40 clinical sites in the US. The Pulmonary Fibrosis Foundation Patient Registry will collect data on at least 2,000 patients at approximately 40 clinical sites in the US. Participants will be asked to complete patient reported outcome (PRO) surveys related to ILD symptoms and quality of life at the time of enrollment and during clinical follow-up visits (Appendix A – PRO Questionnaires). Each patient will donate approximately 30 mL of blood to the Biorepository, which will be separated into plasma, serum, RNA, and DNA.

Hyun Kim
All
18 Years to 99 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02758808
1605M87921
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Inclusion Criteria:

• 18 years old or older
• Understand and sign the informed consent document
• ILD Diagnosis must be made / confirmed at a participating Registry center.
• The diagnostic evaluation must include, at a minimum, a medical history, physical examination, pulmonary function testing and a computerized tomography (CT) scan of the chest.
• If patients exhibit another pulmonary disease (such as emphysema or asthma), the primary disease must be ILD.
• Anticipated additional follow up at the Registry center within one year.
Exclusion Criteria:

• Diagnosed with:
• Sarcoid
• Lymphangioleiomyomatosis (LAM)
• Pulmonary alveolar proteinosis (PAP)
• Cystic fibrosis (CF)
• Amyloidosis
Interstitial Lung Disease (ILD), Idiopathic Pulmonary Fibrosis (IPF)
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FlowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH) (FLASH)

FLASH is a post-market, prospective data collection registry. The intention of this registry is to evaluate the safety and effectiveness of the FlowTriever System for use in the removal of emboli from the pulmonary arteries in the treatment of acute pulmonary embolism (PE). The use of the device will be assessed in a real-world population, with eligibility criteria that closely approximate its use in clinical practice. The study involves no intervention and all medical procedures are standard of care and not research. The device is FDA approved and being used according to the instructions for use and the physician's discretion.

Michael Rosenberg
All
18 Years and over
Phase IV
This study is NOT accepting healthy volunteers
NCT03761173
STUDY00008046
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Inclusion Criteria:

• Clinical signs and symptoms consistent with acute PE
• Echo, CTPA or pulmonary angiographic evidence of proximal filling defect in at least one main or lobar pulmonary artery
• Scheduled for PE treatment with the FlowTriever System per the Investigator's discretion*
• US only: Patients enrolled in the Conservative Therapy Sub-study are not required to meet this inclusion criteria but must instead be scheduled for primary anticoagulation therapy as the primary treatment strategy.
Exclusion Criteria:

• Unable to be anticoagulated with heparin or alternative
• Diagnosis with a minor PE with a less than 0.9 RV/LV ratio
• Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated*
• Imaging evidence or other evidence that suggests, in the Investigator's opinion, the subject is not appropriate for mechanical thrombectomy intervention*
• Life expectancy < 30 days, as determined by Investigator
• Current participation in another investigational drug or device treatment study that, in the Investigator's opinion, would interfere with participation in this study
• US Only Patients enrolled in the Conservative Therapy Sub-study are not required to meet these exclusion criteria
Device: FlowTriever System, Drug: Anticoagulation Agents
PE - Pulmonary Embolism, PE - Pulmonary Thromboembolism
PE, pulmonary embolism, thromboembolism, thrombectomy, FlowTriever, Anticoagulation Medication
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MT2010-09 Primary Immune Deficiency Treatment Consortium (PIDTC). PROJECT 1: A Prospective Natural History Study of Diagnosis, Treatment and Outcomes of Children with SCID Disorders (RDCRN PIDTC #6901)

Christen Ebens
All
Not specified
N/A
This study is NOT accepting healthy volunteers
NCT01186913
1011M93312
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Inclusion Criteria:
Stratum A: Typical SCID (formerly referred to as Classic SCID)- -Subjects who meet the following inclusion criteria and the intention is to treat with allogeneic hematopoietic cell transplant (HCT) are eligible for enrollment into Stratum A (Typical SCID) of the study:
• Absence or very low number of T cells (CD3 T cells <300/microliter) AND
• No or very low T cell function (<10% of lower limit of normal) as measured by response to phytohemagglutinin (PHA) OR
• T cells of maternal origin present. Stratum B: Leaky SCID, Omenn Syndrome, Reticular Dysgenesis- -Subjects who meet the following criteria and the intention is to treat with HCT are eligible for enrollment into Stratum B: Leaky SCID:
• Maternal lymphocytes tested for and not detected AND
• Either one or both of the following (a,b) :
• a.) <50% of lower limit of normal T cell function as measured by response to PHA, OR response to anti-CD3/CD28 antibody
• b.) Absent or <30% of lower limit of normal proliferative responses to candida and tetanus toxoid antigens
• AND at least two of the following (a through e):
• a.) Reduced number of CD3 T cells
• age ≤2 years: <1500/microliter
• age >2 years and ≤4 years: <800/microliter
• age >4 years: <600/microliter
• b.) ≥80% of CD3+ or CD4+ T cells that are CD45RO+
• AND/OR >80% of CD3+ or CD4+ T cells are CD62L negative
• AND/OR >50% of CD3+ or CD4+T cells express HLA-DR (at <4 years of age)
• AND/OR are oligoclonal T cells
• c.) Hypomorphic mutation in IL2RG in a male, or homozygous hypomorphic mutation or compound heterozygosity with ≥1 hypomorphic mutation in an autosomal SCID-causing gene
• d.) Low T Cell Receptor Excision Circles (TRECs) and/or the percentage of CD4+/45RA+/CD31+ or CD4+/45RA+/CD62L+ cells is below the lower limit of normal.
• e.) Functional testing in vitro supporting impaired, but not absent, activity of the mutant protein, AND
• Does not meet criteria for Omenn Syndrome. Omenn Syndrome:
• Generalized skin rash
• Maternal lymphocytes tested for and not detected; --Note: If maternal engraftment was not assessed and ruled out, the subject is not eligible as Omenn Syndrome.
• ≥80% of CD3+ or CD4+ T cells are CD45RO+ AND/OR
• 80% of CD3+ or CD4+T cells are CD62L negative AND/OR
• 50% of CD3+ or CD4+ T cells express HLA-DR (at <2 years of age);
• Absent or low (< 30% lower limit of normal) T cell proliferation response to antigens (Candida, tetanus) to which the subject has been exposed NOTE: If proliferation to antigen was not performed, but at least 4 of the following 9 supportive criteria, at least one of which must be among those marked with an asterisk (*) below are present, the subject is eligible as Omenn Syndrome:
• Hepatomegaly
• Splenomegaly
• Lymphadenopathy
• Elevated IgE
• Elevated absolute eosinophil count
• *Oligoclonal T cells measured by CDR3 length or flow cytometry
• *Proliferation to PHA is reduced <50% of lower limit of normal or SI <30
• *Hypomorphic mutation in a SCID causing gene
• Low TRECS and/or the percentage of CD4+/45RA+/CD31+ or CD4+/45RA+/CD62L+ cells is below the lower limit of normal. Reticular Dysgenesis:
• Absence or very low number of T cells (CD3 <300/µL
• No or very low (<10% lower limit of normal) T cell response to PHA
• Severe neutropenia (absolute neutrophil count < 200 /µL) AND
• ≥2 of the following (a,b,c):
• a.) Sensori-neural deafness
• b.) Deficiency of marrow granulopoiesis on bone marrow examination
• c.) A pathogenic mutation in the adenylate kinase 2 (AK2) gene identified. Stratum C: Subjects who meet the following criteria and the intention is to treat with therapy other than allogeneic HCT, primarily PEG-ADA ERT or gene therapy with autologous modified (gene transduced) cells, are eligible for enrollment into Stratum C:
• ADA Deficient SCID with intention to treat with PEG-ADA ERT
• ADA Deficient SCID with intention to treat with gene therapy
• X-linked SCID with intention to treat with gene therapy
• Any SCID patient previously treated with a thymus transplant (includes intention to treat with HCT, as well as PEG-ADA ERT or gene therapy)
• Any SCID patient who received therapy for SCID deemed "non-standard" or "investigational", including in utero procedures.
Exclusion Criteria:
-Subjects who meet any of the following exclusion criteria are disqualified from enrollment in Strata A, B, or C of the study:
• Presence of an Human Immunodeficiency Virus (HIV) infection (by PCR) or other cause of secondary immunodeficiency
• Presence of DiGeorge syndrome
• MHC Class I and MHC Class II antigen deficiency, and
• Metabolic conditions that imitate SCID or related disorders such as folate transporter deficiency, severe zinc deficiency or transcobalamin deficiency.
Severe Combined Immunodeficiency (SCID), Leaky SCID, Omenn Syndrome, Reticular Dysgenesis, ADA SCID, XSCID
Severe Combined Immunodeficiency (SCID), natural history study, SCID treatment
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Observational study to compare Non-Invasive Venous waveform Analysis (NIVA) with Pulmonary Capillary Wedge Pressure (PCWP) during right heart catheterization

NIVA measurements will be obtained concurrently with pulmonary catheter wedge pressures during right heart catheterization.

Eric Wise
18 Years and over
NA
This study is NOT accepting healthy volunteers
SURG-2021-30253
STUDY000014969
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Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, greater than or equal to 18 years of age
Exclusion Criteria:
Right Heart Catheterization Study Arm & Summative Arm: An individual who meets any of the following criteria will be excluded from participation or data analysis (if found post-hoc around time of RHC) in this study:
• Severe cardiac valvular disease of any cardiac valve, moderate tricuspid disease both regurgitation and stenosis
• Clinical diagnosis of restrictive cardiomyopathy or amyloidosis
• Clinical diagnosis of constrictive pericarditis/cardiac tamponade
• Receiving intravenous: nitrosovasodialtors, epoprostenol, milrinone, dobutamine, dopamine, norepinephrine, phenylephrine, and/or epinephrine.
• Cardiac assist devices (intra-aortic balloon pump, ventricular assist devices, extracorporeal membrane oxygenation)
• Repaired/Unrepaired Cyanotic Heart Disease, Unrepaired septal defect, Obstructive right heart valvular lesions
• Carries the diagnosis of superior vena cava (SVC) syndrome
• Active and/or history of upper extremity Deep Vein Thrombosis (DVT)
• Previous Arterial-Venous Fistula or Graft on NIVA measurement arm
• Active infection or sepsis
• Pregnant or lactating
• Known psychiatric or neurologic disease or prisoners who are unable to consent
• Any other medical condition, which in the opinion of the investigator, would place the patient at undue risk from participating. SARS-CoV2 Study Arm: An individual who meets any of the following criteria will be excluded from participation in this study:
• Severe cardiac valvular disease of any cardiac valve, moderate tricuspid disease both regurgitation and stenosis
• Clinical diagnosis of restrictive cardiomyopathy or amyloidosis
• Clinical diagnosis of constrictive pericarditis/cardiac tamponade
• Receiving intravenous: nitrosovasodialtors, epoprostenol, milrinone, dobutamine, dopamine, norepinephrine, phenylephrine, and/or epinephrine.
• Cardiac assist devices (intra-aortic balloon pump, ventricular assist devices, extracorporeal membrane oxygenation)
• Repaired/Unrepaired Cyanotic Heart Disease, Unrepaired septal defect, Obstructive right heart valvular lesions
• Superior vena cava (SVC) syndrome
• Active and/or history of upper extremity Deep Vein Thrombosis (DVT)
• Previous Arterial-Venous Fistula or Graft on NIVA measurement arm
• Active infection or sepsis
• Known psychiatric or neurologic disease or prisoners who are unable to consent
• Any other medical condition, which in the opinion of the investigator, would place the patient at undue risk from participating.
Diabetes & Endocrine
Clinics and Surgery Center (CSC), NIVA Right Heart Catheterization Study
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Aortic, Peripheral & Venous (APV) PRODUCT SURVEILLANCE REGISTRY (PSR) PLATFORM BASE

Patient-centric, active post-market registry with an extensible design allowing products to be added following market release. Patients are enrolled and followed in accordance with the routine care practices of their care provider.

Jafar Golzarian
Post Market Monitoring
This study is NOT accepting healthy volunteers
NCT01524276
STUDY00013375
Coronary Artery Disease, Aortic, Peripheral Vascular and Venous Disorders, Cardiac Rhythm Disorders, Cardiovascular Disorders, Diagnostic Techniques and Procedures, Digestive Disorders, Intracranial Aneurysm, Mechanical Circulatory Support, Minimally Invasive Surgical Procedures, Neurological Disorders, Neurovascular, Renal Insufficiency, Respiratory Therapy, Surgical Procedures, Operative, Urological Disorders
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APOL1 Long-term Kidney Transplantation Outcomes Network

The National Institutes of Health (NIH)-sponsored collaborative APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO) is charged with prospectively assessing the effects of renal-risk variants (RRVs) in the apolipoprotein L1 gene (APOL1) on outcomes for kidneys from donors with recent African ancestry and the recipients of their kidneys, after deceased- and living-donor renal transplantation. For the purposes of APOLLO, recent African ancestry is defined as individuals with similar genetic make-up to those currently residing in Africa. APOLLO will also study the impact of APOL1 RRVs on the health of living kidney donors with recent African ancestry.

Samy Riad
NA
This study is NOT accepting healthy volunteers
NCT03615235
STUDY00007354
Kidney Disease, Chronic, Kidney Diseases, Kidney Failure
Apolopoprotein L1 gene (APOL1), Association of Organ Procurement Organizations (AOPO), Kidney Donor, Kidney Transplantation, Kidney Transplantation Outcomes Network, United Network for Organ Sharing (UNOS)
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SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion (SLIP II)

We aim to conduct a randomized control trial comparing patient outcomes and satisfaction with or without expert panel review before making a final decision about surgery for grade I degenerative lumbar spondylolisthesis. A prospective multi-center registry aimed at addressing important issues pertaining to outcomes from treatment for degenerative spondylolisthesis and spinal stenosis will be generated.

David Polly
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03570801
STUDY00003517
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Inclusion Criteria:

• Symptomatic lumbar spinal stenosis: defined as radicular and/or back pain either induced or aggravated by activity and relieved by rest.
• Single-level grade I degenerative spondylolisthesis (3-14mm)
Exclusion Criteria:

• Serious medical illness (ASA Class IV or higher)
• Spondylolysis
• Multilevel spondylolisthesis or high grade spondylolisthesis (grade II or greater than 14mm)
Other: Expert Panel Review
Lumbar Spondylolisthesis, Grade 1 Spondylolisthesis, Lumbar Spinal Stenosis, Degenerative Spondylolisthesis, Bone, Joint & Muscle
Lumbar Spondylolisthesis, Grade 1 Spondylolisthesis, Lumbar Spinal Stenosis, Degenerative Spondylolisthesis
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COG APEC14B1 The Project: Every Child Protocol: A Registry, Eligibility Screening, Biology and Outcome Study Additional Title: EVERYCHILD (APEC14B1) PCR - COG Foundation

This research trial studies the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care.

Emily Greengard
All
up to 25 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02402244
1603M85344
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Inclusion Criteria:

• Enrollment must occur within 6 months of initial disease presentation OR within 6 months of refractory disease, disease progression, disease recurrence, second or secondary malignancy, or post-mortem
• Patients previously enrolled on ACCRN07 are eligible to enroll on Tracking Outcome, Registry and Future Contact components of APEC14B1 any time after they reach age of majority
• Patients with a known or suspected neoplasm that occurs in the pediatric, adolescent or young adult populations are eligible for enrollment as follows:
• All cancer cases with an International Classification of Diseases for Oncology (ICD-O) histologic behavior code of two "2" (carcinoma in situ) or three "3" (malignant)
• All neoplastic lesions of the central nervous system regardless of behavior, i.e., benign, borderline or malignant
• The following other benign/borderline conditions:
• Mesoblastic nephroma
• Teratomas (mature and immature types)
• Myeloproliferative diseases including transient myeloproliferative disease
• Langerhans cell histiocytosis
• Lymphoproliferative diseases
• Desmoid tumors
• Gonadal stromal cell tumors
• Subjects must be =< 25 years of age at time of original diagnosis, except for patients who are being screened specifically for eligibility onto a COG (or COG participating National Clinical Trials Network [NCTN]) therapeutic study, for which there is a higher upper age limit
• All patients or their parents or legally authorized representatives must sign a written informed consent and agree to participate in at least one component of the study; parents will be asked to sign a separate consent for their own biospecimen submission
• If patients or their parents or legally authorized representatives have not signed the Part A subject consent form at the time of a diagnostic bone marrow procedure, it is recommended that they initially provide consent for drawing extra bone marrow using the Consent for Collection of Additional Bone Marrow; consent using the Part A subject consent form must be provided prior to any other procedures for eligibility screening or banking under APEC14B1
Other: Cytology Specimen Collection Procedure, Other: Medical Chart Review
Carcinoma In Situ, Central Nervous System Neoplasm, Childhood Immature Teratoma, Childhood Langerhans Cell Histiocytosis, Childhood Mature Teratoma, Congenital Mesoblastic Nephroma, Desmoid Fibromatosis, Lymphoproliferative Disorder, Malignant Solid Neoplasm, Myeloproliferative Neoplasm, Stromal Neoplasm
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EVALUATION OF PATIENT OUTCOMES FROM THE KIDNEY ALLOGRAFT OUTCOMES ALLOSURE REGISTRY (KOAR) (KOAR)

AlloSure KOAR will recruit eligible kidney recipients who are undergoing AlloSure testing as part of their clinical care to participate in a registry. Patient consent will permit collection and use of data from the patient EMR for entry into the AlloSure database. We will be collecting additional data and outcomes to follow the clinical inquiry and use of AlloSure testing. The AlloSure test has been approved for Medicare coverage for clinical use when a physician determines there is a need to assess the probability of allograft rejection in kidney transplant recipients. The DART study suggests that use of the non-invasive AlloSure test to measure donorderived cell-free DNA (dd-cfDNA) can be used to discriminate active rejection in a renal transplant recipient. Use of the test may reduce invasive percutaneous renal biopsy procedures among patients with a suspicion of rejection. Patients may begin use of the AlloSure test 2 weeks following transplantation. The recommended AlloSure testing schedule is at months 1, 2, 3, 4, 6, 9, and 12 post-transplant and quarterly in year 2 and year 3 post-transplant. AlloSure testing may also be performed when there is clinical suspicion of rejection or other cause of instability in the allograft to inform on the need for a clinically indicated biopsy. Patients and clinicians may choose to use AlloSure testing as a replacement or pre-test for planned surveillance biopsies to inform on the decision to perform a surveillance biopsy, but not the one-year surveillance biopsy used to generate the primary endpoint data. This is a multicenter, non-blinded, prospective observational cohort study of 1000 patients enrolled in an AlloSure testing registry, including 300 patients at centers with planned renal surveillance biopsies at 12 months post-transplantation. The other 700 patients will be from centers that do not perform protocol surveillance biopsies. Outcomes in this sub-cohort, which represents the majority of the intended use population in the U.S., will be compared to the outcomes of the test and control cohorts. A matched control cohort of 300 patients will be retrospectively selected from the subset of centers providing the test cohort patients who have planned surveillance biopsies at 12 months post-transplantation.

Arthur Matas, MD
All
18 Years and over
NA
This study is NOT accepting healthy volunteers
NCT03326076
STUDY00002597
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KOAR
Inclusion Criteria:

• Patient's health care provider adopts and intends to apply the center's AlloSure Routine Testing Schedule as part of the information used to manage the patient.
• Subjects willing to provide written informed consent to participate. KOAR
Exclusion Criteria:
___________________________________________________________ Exclusions for AlloSure® Intended Use Specimens from patients for whom any of the following are true will not be tested:
• Recipients of transplanted organs other than kidney
• Recipients of a transplant from a monozygotic (identical)
• Recipients of a bone marrow transplant
• Recipients who are pregnant
• Recipients who are under the age of 18
• Recipient who are less than 14 days post-transplant
Diagnostic Test: Donor-derived cell-free DNA (AlloSure®), Other: Standard care, Diagnostic Test: Peripheral blood gene expression profiling (AlloMap Kidney), Diagnostic Test: Analytic platform (IBox)
Kidney Transplant Rejection
Clinics and Surgery Center (CSC)
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