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Search Results Within Category "Cancer"

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Suggestions within category "Cancer"

163 Study Matches

AREN2231; Risk Adapted Treatment of Unilateral Favorable Histology Wilms Tumors (FHWT)

This study aims to improve the outcomes within cohorts of favorable-histology Wilms tumor (FHWT) patients, and maintain those outcomes despite therapy reduction. In this case, an improved outcome would be considered an improvement in event-free survival rates (EFS). Patients will be stratified to different treatment groups based upon age, response to treatment, and other factors. This trial will include six chemotherapy treatment regimens, and there will also be expansion and refinement of the cohort of patients who are treated with nephrectomy only. Exploratory aims will address aspects such as radiology, surgery, radiation oncology, pathology, and the biological aspects of FHWT.

Principal Investigator: Robin Williams
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025902
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Age: Patients must be more than 30 years old
• Diagnosis: Patients with newly diagnosed Stage I-IV - Favorable Histology Wilms Tumor confirmed by central review and with a qualifying Initial Stratum Assignment received on APEC14B1-REN
Exclusion Criteria:

• Patient with a diagnosis of Stage V Bilateral Wilms Tumor
• Patients who in the opinion of the investigator are not able to comply with the study procedures are not eligible -Patients with any uncontrolled, intercurrent illness including but not limited to symptomatic congestive heart failure
• Patients with Stage I FHWT with a known or suspected Wilms Tumor predisposition syndrome or condition (contralateral nephrogenic rests and/or unilateral multicentric tumors) are excluded from treatment on the mVLR (Nephrectomy Only) arm
Conditions: Cancer, Cancer, Kidney, Prostate & Urinary
Keywords: Wilms Tumors
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A Phase 1b Open-Label Multicenter Study of OP-1250 (Palazestrant) in Combination with the CDK4/6 Inhibitor Ribociclib, with the PI3K Inhibitor Alpelisib, or with the mTOR inhibitor Everolimus in Adult Subjects with Advanced and/or Metastatic ER Positive, HER2 Negative Breast Cancer

The main purpose of this study is to look at how safe and well tolerated the study drug is in combination with ribociclib (Group 1) or alpelisib (Group 2), the levels of the study drug and ribociclib or alpelisib in your blood, and how your body and your cancer respond.

Principal Investigator: David Potter
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001932
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 18 years old
• diagnosis of advanced and/or Metastatic HR Positive, HER2 Negative Breast Cancer
• received no more than 2 prior hormonal regimens for advanced or metastatic disease
• received no more than 1 prior chemotherapy for locally advanced or metastatic breast cancer
Exclusion Criteria:

• significant heart disease
• cerebral vascular disease within 6 months
• pulmonary embolism, or deep venous thrombosis within the last 6 months
• pneumonitis or interstitial lung disease
• history or ongoing gastrointestinal disorders that result in poor absorption of medications
• history of significant liver disease
• study staff will review medical history
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), alpelisib, HER2-neg breast cancer, HR-positive Breast Cancer, Metastatic Breast cancer, ribociclib
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MT2020-35 - COG AAML1831 - A Phase 3 Randomized Trial for Patients With De Novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 With GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients With FLT3 Mutations

The overall goal of this study is to compare the effects, good and/or bad, of CPX-351 with daunorubicin and cytarabine on people with newly diagnosed AML to find out which is better, and to find out what effects, good and/or bad, the drug gilteritinib has when given with chemotherapy to children and young adults with newly diagnosed AML and the FLT3/ITD mutation or non-ITD FLT3 activating mutations.

Principal Investigator: Peter Gordon
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00000965
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• patients must be less than 22 years of age at the time of study enrollment
• all patients must be enrolled on APEC14B1 and consented to Eligibility Screening (Part A) prior to enrollment and treatment on AAML1831
• patient must be newly diagnosed with de novo Acute Myeloid Leukemia (AML)
• see link to clinicaltrials.gov for additional inclusion criteria
Exclusion Criteria:

• any concurrent malignancy
• female patients who are pregnant
• lactating females who plan to breastfeed their infants
• see link to clinicaltrials.com for additional exclusion criteria
Conditions: Cancer
Keywords: Acute Myeloid Leukemia, AML
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Intraperitoneal FT536 in Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

FT536 is a type of cell product made up of “natural killer” or NK cells. NK cells are a type of immune blood cell that are known to attack cancer cells. FT536 is produced by growing cells that come from a healthy human donor. The primary purpose of this study is to identify a safe dose of FT536 cells when given alone (monotherapy).

Principal Investigator: Melissa Geller, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021809
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer that has recurred after treatment (no limit to the maximum number of prior treatments)
• must have received prior bevacizumab
• if there is a BRCA mutation, must have received a prior PARP inhibitor
• agree to the have an intraperitoneal catheter placed before the 1st dose of study drug
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
Exclusion Criteria:

• women who are pregnant, breastfeeding or planning to become pregnant in the next 6 months
• active autoimmune disease requiring systemic immunosuppressive therapy
• history of severe asthma and currently on chronic medications (more than inhalers)
• received enoblituzumab
• CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease or needing medications for these conditions in the past 2 years
Conditions: Cancer, Women's Health
Keywords: Clinics and Surgery Center (CSC), Fallopian Tube Cancer, Gynecologic Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
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Phase I/II, Multi-Center, Open-Label Study of VT3989, Alone or in Combination, in Patients with Locally Advanced or Metastatic Solid Tumors

This study is intended to find the highest amount of the study drug, VT3989, which can be safely taken by patients without causing too many side effects and to determine the recommended dose and dosing schedule for further research, how much of the study drug gets into the blood stream and how long it takes to be cleared, and if the study drug will shrink tumors.

Principal Investigator: Robert Kratzke
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00019430
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• metastatic solid tumor or mesothelioma that has progressed on or after all approved therapies of known clinical benefit
• able to walk and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• active brain metastases or primary CNS (central nervous system) cancer
• HIV positive or active Hepatitis B or Hepatitis C
• significant heart disease
• another active cancer
• women who are pregnant or breastfeeding
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Mesothelioma, solid tumors
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10,000 Families Study

The purpose of this study is to study the evolution of early life risk factors that may lead to cancer and other conditions. This is a prospective cohort study of families who reside in Minnesota.

Principal Investigator: Jen Poynter
Age Group: Not specified
This study is also accepting healthy volunteers
IRB Number: STUDY00000877
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Sex: Male or Female
Age Group: Not specified
This study is also accepting healthy volunteers
Inclusion Criteria:

• 1st Participant: 18+ living in MN
• Other family members: All ages and must live in MN, ND, SD, IA, or WI
• Participants ages 0-17 must have a parent consent to their participation and assist with study activities
Exclusion Criteria:

• Unwilling or unable to provide DNA and blood sample
• Does not have at least 1 living family member in MN IA, ND, SD, or WI
Conditions: Cancer, Microbiota, Prevention & Wellness
Keywords: Minnesota, PFAS, environment, exposures, family, genetics, glyphosate, lifestyle, radon, 10KFS, D2D
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A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician s Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05)

The purpose of this study is to see if sacituzumab govitecan in combination with pembrolizumab can improve outcomes and delay the return of disease in participants with high-risk early Triple Negative Breast Cancer (TNBC) when compared to pembrolizumab alone or pembrolizumab in combination with capecitabine. Participants with low tumor expression of the estrogen and/or progesterone receptors (1 to 10%) will also be included in this study. The study treatment will be chosen by chance—like flipping a coin. There is a 1 out of 2 chances to receive Sacituzumab govitecan in combination with Pembrolizumab and 1 out of 2 chances to receive a study treatment of study doctor’s choice of either pembrolizumab alone or pembrolizumab in combination with capecitabine. Participants and their study doctor will know what study drug is being taken.

Principal Investigator: Anne Blaes, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00021239
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• invasive triple negative breast cancer (TNBC) still remains in the breast or lymph nodes after therapy and surgery
• unable to do physically strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• Stage IV (metastatic) breast cancer or previous cancer in the same or other breast
• evidence that the cancer has reoccurred after preoperative therapy and surgery
• presence of germline breast cancer gene (BRCA) mutations
Conditions: Cancer
Keywords: TNBC, Triple Negative Breast Cancer, Clinics and Surgery Center (CSC)
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MT2022-60: A phase II study of Pembrolizumab+ BEAM conditioning regimen before autologous stem cell transplant (ASCT) followed by pembrolizumab maintenance in patients of relapsed classic Hodgkin lymphoma

This drug study aims to estimate at initiation of treatment to the occurrence of disease progression or expiration at 1 years post autologous stem cell transplant of classical Hodgkin’s lymphoma patients treated with BEAM autologous stem cell transplant combined with pembrolizumab given pretransplant and for 1 year post-transplant maintenance.

Principal Investigator: Sanjal Desai
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020893
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• eligible for autologous stem cell transplant (ASCT) with BEAM conditioning regimen
• unable to do strenuous activities but can walk and perform light or sedentary tasks, such as housework or office work
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• known active central nervous system (CNS) disease
• history of or active autoimmune disease, or other syndrome that requires systemic steroids or autoimmune agents
• had an allogenic tissue/solid organ transplant
• women who are pregnant or breast feeding
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Autologous Stem Cell Transplant, Classic Hodgkin Lymphoma
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An Open-Label, Pilot Clinical Trial To Test The Efficacy Of A Suspension of Freeze-dried Microbiota In Patients Undergoing Colon Resection

We have determined that the microbes (bacteria) in the colon can play a role in causing and preventing complications of colon surgery. While the surgical bowel prep before surgery eliminates the harmful bacteria, it also eliminates the beneficial bacteria that aid wound healing. The purpose of this study is to determine if we can restore the presence of good bacteria (also known as ‘intestinal microbiota’) in the colon by transplanting them from a healthy donor.

Principal Investigator: Cyrus Jahansouz
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023336
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 18 to 75 years old
• having surgery for unresectable polyps, early-stage colon cancer (Stage 1 or 2) and don't expect to have chemotherapy or diverticulitis
• able to provide fecal samples
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• history of inflammatory bowel disease (Crohn's, Ulcerative Colitis)
• women who are pregnant or breastfeeding
• presence of ileostomy or colostomy
• history of solid organ or bone marrow transplant
• history of celiac disease
• receiving cancer chemotherapy, immunotherapy, or radiation
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer, Digestive & Liver Health
Keywords: bowel resection, bowel surgery, Clinics and Surgery Center (CSC), colon cancer
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Cervical and Endometrial Cancer Screening in Patients Seeking Gender-Affirming Hysterectomy

This study aims to quantify the rates of cervical cancer screening and endometrial sampling prior to gender-affirming hysterectomy, assess the need for these tests in TGD individuals, and explore patient-centered options for these tests.

Principal Investigator: Meredith Wise
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023022
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 18 years old
• able to understand, speak, read, and write in English
• have undergone hysterectomy, or plan to have a hysterectomy
• people who are transgender and gender diverse
Exclusion Criteria:

• on the study’s community advisory board
Conditions: Cancer, Community Health
Keywords: Cancer screening, hysterectomy, uterus
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A Phase 2 Multiple Dose Study to Evaluate the Efficacy and Safety of PUL-042 Inhalation Solution in Reducing Lower Respiratory Tract Complications in Patients with Hematologic Malignancies and Recipients of Hematopoietic Stem Cell Transplantation (HSCT) with Documented Viral Infections with Parainfluenza Virus (PIV), Human Metapneumovirus (hMPV) or Respiratory Syncytial Virus (RSV)

The purpose of this research study is to see whether an experimental drug, PUL-042 Inhalation Solution (PUL-042), is effective in reducing the severity of lung infections in patients with hematologic malignancies and recipients of hematopoietic stem cell transplantation with viral infections due to PIV, hMPV, or RSV. Participants will receive PUL-042 or a placebo (an inactive agent that appears identical to PUL-042) through a nebulizer. This is a machine that uses a small motor to turn liquid into a mist, like a humidifier, so you can breathe the drug into your lungs. Participants will receive the experimental drug, PUL-042, or a placebo 3 times over a 6-day period.

Principal Investigator: Jo-Anne Young, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023107
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• nasopharyngeal swab is positive for PIV, RSV, or hMPV (as a single pathogen or a mixed infection with rhinovirus) AND
• diagnosis of a hematologic malignancies (i.e., leukemia, lymphoma, or multiple myeloma) or recipient of an allogeneic or autologous hematopoietic stem cell transplantation for one of the following diagnoses: leukemia, lymphoma, Hodgkin's lymphoma, non-Hodgkin's lymphoma, multiple myeloma, and myelodysplastic and myeloproliferative disorder
• have undergone active chemotherapy within 6 months or are on an immunosuppressive therapy
• symptomatic with upper or lower respiratory tract symptoms such as rhinorrhea, sore throat or cough
• must not be pregnant, plan to become pregnant, or nurse a child during the study and through 30 days after completion of the study
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• pulse oximetry of hemoglobin saturation less than 93% on room air
• history of chronic pulmonary disease (e.g., asthma [including atopic asthma, exercise-induced asthma, or asthma triggered by respiratory infection], chronic pulmonary disease, pulmonary fibrosis, COPD), pulmonary hypertension, or heart failure
• positive for other respiratory viruses (limited to influenza, SARS-CoV-2, adenovirus, or coronavirus) within 7 days
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer, Respiratory System
Keywords: Hematologic Malignancies, Hematopoietic Stem Cell Transplant (HSCT)
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ConnectedNest: a digital platform connecting individuals with cancer to social care

Social determinants of health (SDoH) like housing instability, food insecurity, and financial burden, for example, can negatively affect people dealing with cancer. With new cancer treatments and higher costs for patients, people dealing with cancer may worry more about those issues. The goal of this study is to compare the ways people with cancer are connected to resources addressing specific needs and how those connections help their overall well-being. The research study will take about five months and participants will spend around one hour on research activities (each survey would take less than 15 minutes). The time you spend following up on helpful resources is completely up to participants.

Principal Investigator: Helen Parsons
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022167
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• undergoing active cancer therapy or in survivorship
• must be able to read and write in English
• seen in a participating Minnesota oncology clinic
Exclusion Criteria:

• children
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Cancer
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Continuation of a Home/Community-Based Anal Cancer Screening Unit and Protocol at LGBTQ+ Focused Community Events

This study will help to identify challenges and barriers to self-performing anal cancer screening tests, and may identify unique ways to make this form of screening easier, more cost-effective, and more frequently performed. We believe that it has the potential to minimize the frequency of both disease and death from anal cancer among high-risk patient groups.

Principal Investigator: Elliot Arsoniadis
This study is also accepting healthy volunteers
IRB Number: STUDY00024573
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Sex: Male
This study is also accepting healthy volunteers
Inclusion Criteria:

• at least 35 years old
• assigned sex of “male” at birth
• engage in anoreceptive intercourse with male partners
• willing to provide reliable contact information
• in the case of a positive screen, willing to undergo a clinic visit and HRA
• fluent in English
Exclusion Criteria:

• previous diagnosis of high-grade anal dysplasia or anal cancer
Conditions: Cancer, Community Health, Prevention & Wellness
Keywords: Anal Cancer, Clinics and Surgery Center (CSC)
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A Phase 1B/2, Multicenter, Open-label Study of Ifinatamab Deruxtecan (I-DXd), A B7- H3 Antibody-Drug Conjugate (ADC), In combination with Atezolizumab with or Without Carboplatin as First Line Induction or Maintenance, In Subjects with Extensive-Stage Small Cell Lung Cancer (ES-SCLC) (IDeate-Lung03)

This study is being done to learn more about the safety and effectiveness of ifinatamab deruxtecan (I-DXd) against extensive stage small cell lung cancer.

Principal Investigator: Manish Patel
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022784
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of extensive small cell lung cancer
• have not received any prior treatment (first line therapy)
• may be unable to do physically strenuous activity but able to walk and do work of a light or sedentary nature, e.g., light house work, office work
• agree to use a contraceptive method that is highly effective
• see link to clincialtrials.gov for complete inclusion criteria
Exclusion Criteria:

• any of the following within the past 6 months: cerebrovascular accident, (CVA) transient ischemic attack, (TIA) or another arterial thromboembolic event
• uncontrolled or significant cardiovascular disease
• history of another cancer in the past 5 years
• history of bone marrow, stem cell, or solid organ transplant
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), small cell lung cancer
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HM2024-18 A Phase 1/2, Open-label, Dose-escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP-3654 in Patients with Intermediate or High-risk Primary or Secondary Myelofibrosis

This study is testing an compound called TP-3654, which is an investigational product being developed for Myelofibrosis.

Principal Investigator: Naveen Premnath
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023042
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of primary or secondary myelofibrosis
• may be restricted from strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for complete inclusion criteria which are specified by diagnosis
Exclusion Criteria:

• eligible for allogeneic bone marrow or stem cell transplantation
• history of symptomatic congestive heart failure, or myocardial infarction, or uncontrolled arrhythmia within the past 6 months
• history of chronic liver disease
• women who are pregnant or breastfeeding -see link to clinicaltrials.gov for complete exclusion criteria which are specified by diagnosis
Conditions: Cancer, Rare Diseases
Keywords: Clinics and Surgery Center (CSC), Myelofibrosis
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A non-randomized prospective clinical trial comparing the non-inferiority of salpingectomy to salpingo-oophorectomy to reduce the risk of ovarian cancer among BRCA1 carriers (SOROCk)

The purpose of the study is to compare two surgical procedures and their ability to decrease the risk of developing ovarian cancer for pre-menopausal women with BRCA1 mutations.

Principal Investigator: Britt Erickson
Age Group: 35 years to 50 years old
This study is NOT accepting healthy volunteers
IRB Number: SITE00001183
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Sex: Female
Age Group: 35 years to 50 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 35 to 50 years old
• women with a BRCA1 mutation
• undergoing risk-reducing salpingo-oophorectomy or who have declined or elected to defer BSO
• may be premenopausal or menopausal
Exclusion Criteria:

• history of any prior cancer who have received chemotherapy within the past 30 days or radiotherapy to abdomen or pelvis at any prior time
• women with abnormal screening tests (TVUS, CA-125) suspicious for gross cancer within the past 180 days
• additional criteria apply (study staff will review)
Conditions: Cancer, Women's Health
Keywords: Clinics and Surgery Center (CSC), BRCA1, Ovarian Cancer
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NRG-GY026: A Phase II/III Study of Paclitaxel/Carboplatin Alone or Combined with either Trastuzumab and Hyaluronidase-Oysk (Herceptin Hylecta) or Pertuzumab, Trastuzumab, and Hyaluronidase-Zzxf (Phesgo) in HER2 Positive, Stage I-IV Endometrial Serous Carcinoma or Carcinosarcoma

We are doing this study to see if we can lower the chance of endometrial cancer coming back and causing death by adding a drug or drugs that target HER2 proteins in addition to the usual combination of chemotherapy drugs. We want to find out if this approach is better or worse than the usual approach for your endometrial cancer. The usual approach is defined as care most people get for endometrial cancer, which in this case would be chemotherapy.

Principal Investigator: Britt Erickson
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001733
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• HER2 positive endometrial cancer
• Stage I, II, II or IV endometrial serous or carcinosarcoma
• have not had chemotherapy for treatment of this cancer
Exclusion Criteria:

• pelvic radiation therapy used to treat the tumor
• history of serious heart or lung disease
• plan for hysterectomy after chemotherapy
Conditions: Cancer, Women's Health
Keywords: endometrial carcinosarcoma, Endometrial Serous Adenocarcinoma, Clinics and Surgery Center (CSC)
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A Randomized, Controlled, Multicenter, Phase 3 Clinical Study Comparing Vusolimogene Oderparepvec in Combination with Nivolumab Versus Treatment of Physician s Choice in Patients with Advanced Melanoma That Has Progressed on an Anti-PD-1 and an Anti-CTLA-4 Containing Treatment Regimen [IGNYTE-3]

The purpose of this research is to compare the effects of nivolumab with vusolimogene oderparepvec (VO) against standard of care treatment drug(s) currently available for patients with advanced melanoma. We expect that taking part in this research will last up to 60 months.

Principal Investigator: Benjamin Manning
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023233
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 12 years old
• confirmed metastatic Stage IIIb through IV/M1a through M1d cutaneous melanoma that cannot be surgically removed
• disease progression (PD) on an approved anti-PD-1 and an anti-CTLA-4 treatment, administered either as a combination regimen (eg, nivolumab + ipilimumab) or in sequence for at least 8 weeks
• documented BRAF V600 mutation status
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• more than 2 lines of systemic therapy for advanced melanoma
• known acute or chronic hepatitis
• known human immunodeficiency virus (HIV) infection
• prior cancer in the previous 3 years, except for locally curable cancers that have apparently been cured
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Advanced Melanoma, Melanoma
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MT2018-19: COG ANBL1531 - A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or ALK Inhibitor Therapy Added to Intensive Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma (NBL) (IND# 134379)

This partially randomized phase III trial studies iobenguane I-131 or ALK Inhibitor Therapy and standard therapy in treating younger patients (365 days to 30 years of age) with newly-diagnosed high-risk neuroblastoma or ganglioneuroblastoma.

Principal Investigator: Robin Williams
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00000265
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Age: Patient must be ≥ 365 days and ≤ 30 years of age at diagnosis
• Diagnosis: Patients must have a diagnosis of neuroblastoma or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites
• The following disease groups are eligible: INRG Stage M & MYCN amplification or age > 547 days OR INRG Stage MS disease with MYCN amplification OR INRG Stage L2 disease with MYCN amplification
Exclusion Criteria:

• Patients who have an INRG Stage L2 tumor without amplification of MYCN
• Patients with bone marrow failure syndromes
• Pregnancy and Breastfeeding
Conditions: Cancer
Keywords: high risk, metastatic, neuroblastoma
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AOST2032; A Feasibility and Randomized Phase 2/3 Study of the VEFGR2/MET Inhibitor Cabozantinib in Combination with Cytotoxic Chemotherapy for Newly Diagnosed Osteosarcoma

This phase II/III trial tests the safety, side effects, and best dose of the drug cabozantinib in combination with standard chemotherapy, and to compare the effect of adding cabozantinib to standard chemotherapy to standard chemotherapy alone in treating patients with newly diagnosed osteosarcoma. Cabozantinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. The drugs used in standard chemotherapy for this trial are methotrexate, doxorubicin, and cisplatin. Methotrexate stops cells from making DNA and may kill tumor cells. It is a type of antimetabolite. Doxorubicin is in a class of medications called anthracyclines. It works by slowing or stopping the growth of tumor cells in the body. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Adding cabozantinib to standard chemotherapy may work better in treating newly diagnosed osteosarcoma.

Principal Investigator: Robin Williams
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001870
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• less than 40 years old
• new diagnosis of osteosarcoma of any site
Exclusion Criteria:

• previous treatment for osteosarcoma
• brain metastasis
• history of high blood pressure (140/90) that has required medication
• women who are pregnant or breast feeding
Conditions: Cancer
Keywords: Osteosarcoma
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HM2021-31: A Phase 1b Open-Label Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination with Other Anti-cancer Agents in Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)

The purpose of this study is to evaluate if the investigational combination of drug called loncastuximab tesirine in combination with another anti-cancer agent is a safe and effective treatment for patients with relapsed or refractory B-cell Non-Hodgkin Lymphoma.

Principal Investigator: Marie Hu
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00015805
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of relapsed (disease that has recurred following a response) or refractory (disease that failed to respond to prior therapy) B-Cell Non-Hodgkin Lymphoma (B-NHL)
• able to walk and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• previous treatment with polatuzumab vedotin, glofitamab or mosunetuzumab
• stem cell transplant within 60 days prior to start of study drug
• Human immunodeficiency virus (HIV) seropositive
• women who are pregnant or breast feeding
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), B-Cell Non-Hodgkin Lymphoma, B-NHL
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An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of Intestinal Microbiota Transplantation In Patients Undergoing Colon Resection

We have determined that the microbes (bacteria) in the colon can play a role in causing and preventing complications of colon surgery. While the surgical bowel prep before surgery eliminates the harmful bacteria, it also eliminates the beneficial bacteria that aid wound healing. The purpose of this study is to determine if we can restore the presence of good bacteria (also known as ‘intestinal microbiota’) in the colon by transplanting them from a healthy donor.

Principal Investigator: Cyrus Jahansouz
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00019579
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 18 to 75 years old
• having surgery for diverticulitis or sigmoid colon cancer
• able to provide fecal samples
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• history of inflammatory bowel disease (Crohn's, Ulcerative Colitis)
• women who are pregnant or breastfeeding
• presence of ileostomy or colostomy
• history of solid organ or bone marrow transplant -receiving cancer chemotherapy, immunotherapy, or radiation
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer, Digestive & Liver Health
Keywords: c-diff, Clinics and Surgery Center (CSC), colon cancer, colon surgery, gut health, microbiota transplant
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HM2017-24 : Phase I/II Study of Nivolumab in Combination with Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma: BTCRC-HEM-027

Participants who take part in this study will receive a study drug called ruxolitinib with a standard drug called nivolumab. The study is being done to measure the percentage of tumor (lymphoma) that shrinks after receiving ruxolitinib in combination with nivolumab. This study will also measure the length of time the lymphoma is inactive and how safe the combination is to administer to participants. Ruxolitinib is a pill that is taken twice every day. Nivolumab is given as an infusion in the clinic once every 4 weeks.

Principal Investigator: Veronika Bachanova, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00001341
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• age 18 or older
• able to walk and do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• confirmed diagnosis of classical Hodgkin lymphoma that has reoccurred or not responded to treatment
• women and men who are of child bearing age must use required birth control
• there are additional criteria for prior treatment and laboratory results (study staff will review)
Exclusion Criteria:

• inability to swallow oral medication or any condition that affects absorption of oral medications
• women who are pregnant or breast feeding
• additional criteria about current medical history (study staff will review)
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Hodgkin Lymphoma
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MT2024-08: Phase I open-label, dose escalation trial of BI 1831169 monotherapy and in combination with an anti-PD-1 mAb in patients with advanced or metastatic solid tumors.

This study tests the use of the oncolytic virus BI1831169 (VSV-GP) as an immunotherapy in patients with advanced solid tumors. This trial is the first-in-human trial to test the safety and early efficacy of BI1831169 by itself (Part 1) and in combination with the PD-1 inhibitor ezabenlimab (Part 2).

Principal Investigator: Manish Patel
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00019229
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• confirmed diagnosis of an advanced, and/or metastatic or relapsed/refractory solid tumor that can not be surgically removed
• must have exhausted available treatment options or refused established treatment options
• restricted from physically strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for additional Inclusion criteria
Exclusion Criteria:

• major surgery or radiation therapy in the past 4 weeks
• active hepatitis B or C infection
• severe or serious, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation (study staff will review)
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Solid Tumors, Clinics and Surgery Center (CSC)
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Assessment of Breast and Nipple Sensation Following Nerve Grafting in DIEP Flap Breast Reconstruction: A Prospective Study Using Two-Point Discrimination and Semmes-Weinstein Monofilaments

This study is about quality of life and physical sensation in the nipple-areola area of people who have undergone deep inferior epigastric perforator (DIEP) flap breast reconstruction with or without nerve grafting. At the post-operative clinic visits at 3, 6, 12, and 18-months post-op, participants will have sensory assessments and be asked to complete a series of questionnaires.

Principal Investigator: Umar Choudry
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025141
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 18-90 years of age
• assigned gender of female at birth
• having a DIEP flap breast reconstruction with nerve grafting of one or both breasts
Exclusion Criteria:

• peripheral neuropathy or sensory deficits
• having an alternative reconstruction technique or a revision
Conditions: Cancer
Keywords: Breast cancer, DIEP breast reconstruction, reconstructive breast surgery
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MT2015-29 : Myeloablative Allogeneic Hematopoietic Cell Transplantation Using a Related or Adult Unrelated Donor for the Treatment of Hematological Disorders

The primary research element is to determine whether a graft-versus-host disease (GVHD) prophylaxis regimen of post-transplant cyclophosphamide, tacrolimus and MMF will reduce the likelihood of chronic GVHD in patients receiving a standard hematopoietic myeloablative stem cell transplant. The treatment related components of this protocol are established clinical practices. We are looking at cumulative incidence of chronic GVHD requiring systemic immunosuppressive treatment at 1 year post-transplant.

Principal Investigator: Punita Grover
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00001087
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• no more than 60 years old
• may be unable to work; able to live at home and care for self
• women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria (differ by diagnosis)
Exclusion Criteria:

• if ≤ 18 years old, prior myeloablative transplant within the last 6 months. If >18 years old prior myeloablative allotransplant or autologous transplant
• active central nervous system cancer
• active HIV infection or known HIV positive serology
• active uncontrolled infection
• women who are pregnant or breast feeding
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Acute Leukemia, Acute Myeloid Leukemia, ALL, AML, HSCT
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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.

Principal Investigator: Robin Williams
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00000151
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 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
• patients with a known or suspected neoplasm that occurs in the pediatric, adolescent or young adult populations
• 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
• see link to clinicaltrials.gov for additional inclusion criteria
Conditions: Cancer
Keywords: childhood cancer
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AOST2031: A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

This phase III trial compares the effect of open thoracic surgery (thoracotomy) to thoracoscopic surgery (video-assisted thoracoscopic surgery or VATS) in treating patients with osteosarcoma that has spread to the lung (pulmonary metastases). Open thoracic surgery is a type of surgery done through a single larger incision (like a large cut) that goes between the ribs, opens up the chest, and removes the cancer. Thoracoscopy is a type of chest surgery where the doctor makes several small incisions and uses a small camera to help with removing the cancer. This trial is being done evaluate the two different surgery methods for patients with osteosarcoma that has spread to the lung to find out which is better.

Principal Investigator: Robin Williams
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00001674
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 50 years of age or younger
• have 4 or less nodules in the lung due to metastases or suspected metastases
• diagnosis of osteosarcoma
• contact study team for more detailed criteria
Exclusion Criteria:

• pleural or mediastinal based metastatic lesions, or with pleural effusion
• large, or central tumors that require a lobectomy or pneumonectomy
Conditions: Cancer
Keywords: lung cancer, osteosarcoma, pulmonary metastases, thoracotomy
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RANDOMIZED PHASE III TRIAL OF NEOADJUVANT IMMUNOTHERAPY WITH RESPONSE-ADAPTED TREATMENT VERSUS STANDARD-OFCARE TREATMENT FOR RESECTABLE STAGE III/IV CUTANEOUS SQUAMOUS CELL CARCINOMA

We are studying the use of immunotherapy before and after (in some cases) surgery to see if it will extend the length of time until the cancer returns compared to the usual approach. The usual approach for patients who are not in a study is treatment with surgery which may be followed by radiation. Participants will either get the study drug cemiplimab (REGN2810) before surgery for the cancer or will have up-front surgery. For those who receive cemiplimab (REGN2810), it will be given before surgery every 3 weeks for up to 12 weeks. In either case, participants may also receive radiation after surgery depending on the tumor tissue results from surgery.

Principal Investigator: Curtis Hanba
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025188
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of invasive cutaneous squamous cell carcinoma (CSCC) or regional lymph node or in-transit metastasis of CSCC
• previously untreated or recurrent CSCC
• walking and able to do self-care, but unable to work; up and about at least 50% of waking hours
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• women who are pregnant or breastfeeding
• history of solid organ or bone marrow transplant
• no active, known, or suspected autoimmune disease for the past 5 years
• current significant medical issues
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Eyelid Squamous Cell Carcinoma, Recurrent Skin Squamous Cell Carcinoma, Clinics and Surgery Center (CSC)
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ANBL2131/MT2024-35- A Phase 3 Study of Dinutuximab Added to Intensive Multimodal Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma

This phase III trial tests how well adding dinutuximab to induction chemotherapy along with standard of care surgery radiation and stem cell transplantation works for treating children with newly diagnosed high risk neuroblastoma. Dinutuximab is a monoclonal antibody that binds to a molecule called GD2, which is found in greater than normal amounts on some types of cancer cells. This helps cells of the immune system kill the cancer cells. Chemotherapy drugs such as cyclophosphamide, topotecan, cisplatin, etoposide, vincristine, dexrazoxane, doxorubicin, temozolomide, irinotecan and isotretinoin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing or by stopping them from spreading. During induction, chemotherapy and surgery are used to kill and remove as much tumor as possible. During consolidation, very high doses of chemotherapy are given to kill any remaining cancer cells. This chemotherapy also destroys healthy bone marrow, where blood cells are made. A stem cell transplant is a procedure that helps the body make new healthy blood cells to replace the blood cells that may have been harmed by the cancer and/or chemotherapy. Radiation therapy is also given to the site where the cancer originated (primary site) and to any other areas that are still active at the end of induction.

Principal Investigator: Robin Williams
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022164
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Age: less than or equal to 30 years at the time of initial diagnosis with high-risk disease Diagnosis
• Must have a diagnosis of NBL or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamines
• Newly diagnosed, HRNBL defined as one of the following: a. Any age with International Neuroblastoma Risk Group (INRG) Stage L2, MS, or M and MYCN amplification b. Age:: greater than or equal to 547 days and INRG Stage M regardless of biologic features c. Any; age initially diagnosed with INRG Stage L1 MYCN amplified NBL who have progressed to Stage M without systemic chemotherapy d. Age: greater than or equal to 547 days of age initially diagnosed with INRG Stage L1, L2, or MS who have progressed to Stage M without systemic chemotherapy BSA: Patients must have a BSA greater than or equal to 0.25 m2
Exclusion Criteria:

• Patients who are 365-546 days of age with INRG Stage M and MYCN non-amplified NBL, irrespective of additional biologic features.
• Patients ≥547 days of age with INRG Stage L2, MYCN non-amplified NBL, regardless of additional biologic features.
• Patients with known bone marrow failure syndromes.
• Patients on chronic immunosuppressive medications
• Patients with a primary immunodeficiency syndrome who require ongoing immune globulin replacement therapy.
• Female patients who are pregnant or breastfeeding their infant.
Conditions: Cancer
Keywords: neuroblastoma
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