Search Results
Biomarker Stratified CaboZantinib (NSC#761968) and NivOlumab (NSC#748726) (BiCaZO) - A Phase II Study of Combining Cabozantinib and Nivolumab in Participants With Advanced Solid Tumors (IO Refractory Melanoma or HNSCC) Stratified by Tumor Biomarkers - an immunoMATCH Pilot Study
The goal of this study is to evaluate the combination of cabozantinib and nivolumab in people with advanced melanoma or squamous cell head and neck cancer. Researchers want to learn whether these drugs can help shrink or stabilize cancer and whether certain tumor biomarkers may help predict how well patients respond to treatment.
• diagnosis of advanced melanoma or squamous cell head and neck cancer
• cancer has worsened during or shortly after prior PD-1 immunotherapy treatment
• able to care for yourself and perform most daily activities
• must not be pregnant or breastfeeding
• see link to clinicaltrials.gov for complete inclusion criteria
A double blind, randomized, placebo-controlled exploratory trial to investigate the efficacy and safety of nerandomilast over 24 months when administered in individuals with interstitial lung abnormalities and a family history of pulmonary fibrosis to reduce the risk of worsening (DROP-FPF)
The purpose of this study is to find out if a study drug called nerandomilast can help slow down or reduce worsening lung scarring in people with a family history of pulmonary fibrosis. This study compares nerandomilast with a placebo to see if there is a difference in lung changes seen on scans and lung function over time. The placebo looks like nerandomilast but does not contain any active drug.
• at least 40 years old
• have at least 1 close biological family member (parent, sibling, or child) diagnosed with pulmonary fibrosis or a related lung scarring condition
• imaging scan showing early signs of lung scarring or interstitial lung disease (ILD)
• see link to clinicaltrials.gov for complete Inclusion criteria
• known or more advanced pulmonary fibrosis that may require treatment with approved therapies
• medical conditions known to increase the risk of pulmonary fibrosis, such as some connective tissue diseases
• prior or current use of certain pulmonary fibrosis medications including nerandomilast, nintedanib, or pirfenidone
• see link to clinicaltrials.gov for complete Exclusion criteria
Neural Bases of Disgust Conditioning in Anorexia Nervosa
We are studying the brain patterns of people who have anorexia nervosa and those who don't have anorexia nervosa. We will look at MRIs, behavioral measures, and questionnaires to see if we can identify the brain activity associated with disgust. There will be a follow-up at 6 and 12 months.
• Anorexia Nervosa Participants: females between 18- 50 years old who meet criteria for diagnosis of Anorexia Nervosa
• Healthy Participants: healthy females age between 18-50, no previous diagnosis of Anorexia Nervosa or other psychiatric disease.
• Meets criteria for substance abuse disorder or actively suicidal
• Neurological condition or other developmental disorder
• MRI contraindication
• Inability to read English
A randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety, efficacy, and pharmacokinetics of budesonide extended-release tablets administered once daily in pediatric subjects aged 5 to 17 years with active, mild to moderate ulcerative colitis
The purpose of this research study is to test the safety and effectiveness of Budesonide in low and high dose extended- release tablets in pediatric participants with active, mild to moderate Ulcerative Colitis and to evaluate the level of budesonide that remains in the blood after taking it. Participants will be asked to take an oral (by mouth) form of Budesonide or a placebo once daily for 8 weeks. A placebo is a tablet that does not contain any active study drug (Budesonide).
• 5 to 17 years old
• diagnosis of Ulcerative Colitis (UC)
• weight is greater than 13.6 kg (30 pounds)
• active UC of mild or moderate severity
• see link to clinicaltrials.gov for complete inclusion criteria
• current or prior diagnosis of Crohn's disease or indeterminate colitis
• prior gastrointestinal surgery, except appendectomy or hernia
• see link to clinicaltrials.gov for complete exclusion criteria
MT2025-06: Postmarketing, Prospective, Observational, Study to Assess and Characterize the Risk of Secondary Malignancies, and Long-term Safety Following Treatment with atidarsagene autotemcel (Lenmeldy )
To assess and characterize the risk of malignancies, and long-term safety following treatment with atidarsagene autotemcel (Lenmeldy).
• live in the United States
• has been or will be treated for MLD with Lenmeldy
Technology Assisted Treatment for Binge Eating Disorder
This research is being done to study binge eating and potential treatment strategies. An app on a sensor logging device will log eating behavior data. The device will incorporate data and refine the performance of the HabitAware sensor logging model to recognize binge eating episodes. We hope this research will help inform novel treatments for targeting binge eating behavior.
• adults between the ages of 18 and 65 years
• diagnosis of bulimia nervosa, binge eating disorder, or other eating disorder
• women who are pregnant or breast feeding
• history of psychosis or bipolar disorder
• substance use disorder within the past six months
• BMI less than 18.5 kg/m2
• history of acute suicidality requiring hospitalization
• food allergies
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants with Immunoglobulin A Nephropathy (IgAN) (I CAN)
To evaluate the efficacy of ravulizumab compared with placebo to reduce proteinuria in adult participants with IgAN
• Immunoglobulin A Nephropathy (IgAN) diagnosis established on kidney biopsy
• stable and maximum allowed or tolerated RASI (ACEI and/or ARB) dose for ≥ 3 months prior to starting the study
• if receiving SGLT2I, DEARA, MRA or ERA must be on a stable and maximum allowed or tolerated dose for ≥ 3 months prior to starting the study
• see link to clinicaltrials.gov for complete Inclusion criteria
• diagnosis of rapid progressive glomerulonephritis
• clinically significant renal disease other than IgAN
• uncontrolled diabetes mellitus with glycosylated hemoglobin (HbA1c) > 8.5%
• history of kidney transplant or planned kidney transplant
• see link to clinicaltrials.gov for complete Exclusion criteria
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.
• 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
• 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
NRG-BN013: Phase III Trial of Single Fraction Stereotactic Radiosurgery (SRS) versus Fractionated SRS (FSRS) for Intact Brain Metastases
We are doing this study to compare the effectiveness of Single Fraction Stereotactic Radiosurgery (SRS) to radiation treatment called fractionated SRS (or FSRS). SRS delivers a high dose of radiation in a single treatment to the small areas of cancer in the brain. FSRS that delivers a high dose of radiation given over 3 treatments. Both SRS and FSRS only deliver radiation to the small areas of cancer in the brain and minimizes dose to the surrounding normal brain tissue.
• diagnosis of one of the following solid tumor malignancies within 5 years prior to registration: non-small cell lung cancer (NSLS), melanoma, breast cancer, renal cell cancer, gastrointestinal cancer
• no prior radiotherapy to the brain
• see link to clinicaltrials.gov for complete inclusion criteria
Tic Clips
This study is about learning more about the full range of what tics can look like. Participating includes filling out surveys and submitting two brief videos of yourself. We know tics can be really different across people. By getting a lot of videos of people doing tics, we hope to better understand the variety of tics that exist.
• Aged 4 years or older
• Self-report having tics
• Adult participant or parent is able to read in English
• Access to an internet connected device with video recording capability
A Phase 1a/b Study of ADRX-0405 in Subjects with Select Advanced Solid Tumors
This study aims to evaluate the safety and tolerability of ADRX-0405 in people with advanced cancer and determine the optimal dose for treatment.
• age 18 or older
• Phase 1a: confirmed advanced solid tumors (metastatic castration resistant prostate cancer (mCRPC), gastric cancer (GC), and non-small cell lung cancer (NSCLC))
• Phase 1b: confirmed prostate adenocarcinoma that is confirmed to be castration resistant and that is intolerant/resistant to standard of care (SOC) therapies
• see link to clinicaltrials.gov for complete inclusion criteria
• active and uncontrolled central nervous system metastases
• have received an anticancer or investigational therapy prior to the first dose of study drug
• history of ILD/pneumonitis requiring steroid treatment within the past 2 years, current ILD/pneumonitis, or an active infection requiring systemic antibiotics (prophylactic antibiotics permitted)
• see link to clinicaltrials.gov for complete exclusion criteria
Standardized Microbiota Transplant Therapy in Crohn's Disease
The goal of this study is to determine if healthy donor microbes released in the small intestine act the same way as healthy donor microbes released in the large intestine for people with Crohn's Disease. We will see what good bacteria are present in intestinal biopsies at 8 weeks and look for improvement in inflammation with colonoscopy.
• 18 to 89 years old
• English speaking
• Diagnosis of Crohn's Disease (CD)
• currently experiencing a flare (Study will enroll people through 2027)
• Current CD therapies are in the maintenance phase of dosing
• Women who could become pregnant must remain abstinent or use a highly effective form of birth control (e.g., oral contraception, transdermal patch, barrier, intrauterine device)
• See link to clinicaltrials.gov for complete inclusion and exclusion criteria
• Extensive bowel resection or ileostomy or colostomy
• Diagnosis of ulcerative colitis
• Women who are pregnant or breastfeeding
• History of anaphylactic food allergies
Neuroplasticity in REM Sleep Behavior Disorder
REM sleep behavior disorder may predict the eventual symptom development of Parkinson’s disease, dementia with Lewy bodies, or multiple system atrophy. This occurs over years to decades and the sleep disorder may hide other typical symptoms and result in a delay in diagnosis. We are studying the changes in the brain over two years. We will do high field MRI’s (7T) and other tests of neurological function of people who have REM sleep disorder and people who don’t have this disorder (matched for age and sex).
HM2023-43: A phase 2 trial of tafasitamab in combination with lenalidomide+rituximab in treatment-naive follicular lymphoma and marginal zone lymphoma
This study is to see if patients who get tafasitamab in addition to the standard regimen of lenalidomide and rituximab when they are just starting treatment are more likely to stay in remission after treatment than those who do not. We expect that participants will be in this research study for approximately 3 years total. Patients will be on active treatment for approximately 1 year.
• confirmed marginal zone lymphoma
• have not received systemic therapy for lymphoma
• need treatment because of bulky disease, associated symptoms, or causing problems with vital organs (heart, spleen, lung)
• see link to clinicaltrials.gov for complete Inclusion criteria
• active HIV, Hepatitis B, Hepatitis C
• prior history of lenalidomide use
• history of another cancer in the past 5 years
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete Exclusion criteria
Balance4Mobility: Effects of Walkasins Use on Clinical Outcomes of Gait and Balance Function in Individuals with Peripheral Neuropathy and Balance Problems - A Randomized Control Trial
The main purpose of this study is to test whether Walkasins can help people with peripheral neuropathy maintain their balance better. Walkasins have been developed to improve balance and walking by enhancing a person’s ability to feel the pressure beneath his/her feet as he/she walks.
• at least 55 years old
• able to complete all activities without the use of an assistive device
• diagnosis of peripheral neuropathy (if due to chemotherapy, must be 1 year after completion)
• experiencing problems with gait or balance
• able to stand on one leg for at least 30 seconds
• acute thrombophlebitis, including deep vein thrombosis, or severe peripheral vascular disease
• lymphedema
• swelling, infection, inflamed area of skin or eruptions on the lower leg
• weigh more than 300 pounds
Development of Tobacco Related Biomarkers
To maintain a biorepository (sample bank) of biological samples from different tobacco users and non-users to investigate how tobacco and nicotine products affect our bodies. The samples will be used by researchers to develop methods to look for biological “markers” (biomarkers), or chemical changes in the body, that occur due to tobacco or nicotine exposure. The goal is to eventually use these biomarkers to improve detection, prevention, and treatment strategies for tobacco-related diseases.
• formerly smoked cigarettes daily
• uses smokeless tobacco
• smokes cigars
• uses nicotine gum, lozenges, patches, nasal spray, pouches, or inhaler
• younger than 21 years old
• unstable health condition
A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With subsequent Adalimumab or Verapamil in New Onset Type 1 Diabetes (WAVE T1D)
This study is looking at if we give ATG followed by either adalimumab or verapamil if those combinations will help in preserving insulin secretion 2 years after newly diagnosed type 1 diabetes.
• age 9 to <21 years
• recently diagnosed with T1D and can start the treatment phase within 6 months of diagnosis
• body weight more than 66 pounds
• fully vaccinated for age and willing to avoid certain live vaccines during the study
• able to read and understand English or Spanish
• use only insulin to control blood sugar (no other glucose-lowering medicines)
• see link to clinicaltrials.gov for complete Inclusion criteria
• history of serious bacterial, viral, fungal, or other infections or current active infection
• history of underlying heart disease
• history of cancer other than of skin
• severe allergy to milk or adhesives
• see link to clinicaltrials.gov for complete Exclusion criteria
Prefrontal Cortical Stimulation in Severe Treatment Resistant Depression
This study looks at the use of an implanted brain stimulator for people who have treatment resistant depression. The change in brain function by EEG and symptoms of depression will be examined. This study is open to people 22-70 years old with Medicare or Medicare Advantage insurance.
• ages 22-55
• diagnosis of chronic (greater than or equal to 2 years) depression
• poor response to three or more antidepressant medications (staff will review)
• had or refused ECT therapy
• under the regular care of a psychiatrist
• enrolled in a Medicare program
• have at least two people over 22 years of age and live within 30 minutes of participants residence who could respond to study staff if needed
• able to have a MRI scan
• actively suicidal or have a history of an attempt within the last year
• have a history of another major mental health diagnosis
• have a positive drug test
• have an implanted brain device
• pregnant
• history of seizures
Research Evaluating Vagal Excitation and Anatomical Links
We are studying the effects of stimulating the vagus nerve. The vagus nerve connects the brain to many organs in the body. Vagus nerve stimulation (VNS) is already approved by the United States Food and Drug Administration (FDA) to treat depression and epilepsy. We want to learn more about how it affects other parts of our bodies, such as the heart, metabolism, the immune system, and the nervous system. We hope that by understanding how VNS affects the body as a whole, we can develop new treatments for other conditions, or help to improve its use for depression and epilepsy.
• previously implanted with a vagal nerve stimulator (VNS) device to treat Major Depressive Disorder and on stable medications for at least 2 months
• OR will receive a VNS implant as standard clinical care, for Major Depressive Disorder and will receive VNS clinical standard of care programming after study completion. standard clinical care, for Major Depressive Disorder and will receive VNS clinical standard of care programming after completing the study
• OR previously been implanted with a VNS for Epilepsy that isn't controlled with medication
• OR will receive a VNS implant as standard clinical care, and will receive VNS clinical standard of care programming after study completion
• Contact study staff for additional requirements for each group
• willing to use effective birth control for the entire time period of the study
• has a prior implantable stimulation device, other than a VNS device
• uses or is expected during the study to use short-wave diathermy, microwave, diathermy, or therapeutic ultrasound diathermy
• unable to speak English
• additional medical or mental health issues (study staff will review)
A randomised, double-blind, placebo-controlled trial with an open-label extension to assess the pharmacokinetics, safety, and efficacy of empagliflozin tablets in paediatric patients with chronic kidney disease (EMPA-KIDNEY® Kids)
This study is for children aged 2 to 17 with chronic kidney disease (CKD). The purpose of this study is to find out if a study drug called empagliflozin helps children and adolescents with CKD. Other goals of the study are to find out how empagliflozin is tolerated and handled by the body in children and adolescents with CKD.
• 2 to 17 years old
• Chronic kidney disease (CKD) of any type
• on a stable dose of maximally tolerated standard therapy for at least 30 days
• see link to clinicaltrials.gov for complete Inclusion criteria
• Type 1 or Type 2 diabetes mellitus
• chronic dialysis or functioning kidney transplant or scheduled for transplantation
• Body mass index (BMI) ≤10th percentile for children ≥4 years of age and ≤25th percentile for children <4 years of age
• gastrointestinal disorders that might interfere withdrug absorption
• see link to clinicaltrials.gov for complete Exclusion criteria
Characterizing Neuropathic Pain in Individuals Receiving Inpatient Treatment for an Alcohol Use Disorder
This study aims to learn more about neurological symptoms associated with alcohol use. The study team plans to characterize neuropathic pain in individuals receiving in-patient treatment for alcohol use compared with moderate drinkers of the same age.
• between 21 and 65 years of age
• must speak English
• Moderate drinkers group: Use alcohol at least 2-4 times per month
• Treatment group: patients in the Fairview Lodging Program primarily seeking treatment for alcohol - use of nicotine, cannabis, cocaine, and hallucinogens are permissible
Department of Neurology Movement Disorders Research Registry
The purpose of the University of Minnesota (UMN) movement disorders research registry is to connect individuals interested in participating in Movement Disorders research with researchers at the University of Minnesota. The registry will allow individuals from the community to share their contact information, basic information about their health diagnoses, and research studies they participate in. This information will be stored for future research contact and be used to determine which movement disorders studies (if any) that an individual may qualify for. Click 'Visit the Study Website' to learn more and to sign up for the registry.
• interested in participating in movement disorders research at UMN
MT2025-36: Phase 2/3 Randomized Study of Tebentafusp as Monotherapy and in Combination with Pembrolizumab Versus Investigator s Choice in HLA-A*02:01-positive Participants with Previously Treated Advanced Melanoma (TEBE-AM)
This study is about treatment of Melanoma (a kind of skin cancer) that has spread or cannot be surgically removed and has gotten worse after standard treatments. This study includes patients with melanoma from any part of the body except the eye. The main purpose of this study is to learn if the study medicine (tebentafusp), alone or a combination with pembrolizumab, helps patients with advanced melanoma live longer. The combination of pembrolizumab and tebentafusp used in this study is experimental.
• unresectable Stage III or Stage IV non-ocular melanoma
• may not be able 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 criteria
• women who are pregnant or breastfeeding
• diagnosis of ocular or metastatic uveal melanoma
• history of a another type of cancer
• unable to be retreated with pembrolizumab because of a previous severe side effect
• significant pulmonary or cardiac disease or impaired lung or cardiac function
• known psychiatric or substance abuse disorders
• see link to clinicaltrials.gov for complete Exclusion criteria
Assessment of usability and satisfaction with a take-home device presenting sound and body stimulation for back pain
The purpose of this study is to measure the compliance, usability, and satisfaction of an at-home, multi-modal stimulation device in a diverse population of people with chronic lower back pain (cLBP) compared to a group of participants who are engaging in integrative health practices. The multi-modal device will include a combination of electrical stimulation, auditory stimulation, and integrative-health techniques, including mindfulness breathing, health coaching, and reflective journaling. The multi-modal device creation is based on prior knowledge in lower back pain treatment, which includes electrical stimulation of the back (Transcutaneous Electrical Nerve Stimulator or TENS) and integrative health modalities. Findings from this usability pilot study could help refine the approach and the multi-modal device for a future intervention study in cLBP participants.
• must have chronic lower back pain, defined as back pain lasting 3 or more months,
• willing to travel to the University of Minnesota and commit to the study duration
• cannot have any implanted stimulation devices
Improving Barriers to Care Access for Children with Autism and Related Needs via Telehealth for Evaluation, Care Navigating, and Caregiver Coaching
Researchers at the University of Minnesota, Twin Cities are looking for research participants for a study about the efficacy of early intervention services provided over telehealth (video conferencing) for kids ages 1-5 years old with Autism Spectrum Disorder (ASD) and their families. This study is also intended to test the training of community providers in the use of this model. Parents will receive coaching to provide interventions to support their child’s communication and other skills. You and your child may be eligible if your child is between 1 and 5 years old, your child is on a waitlist to be evaluated for ASD or has received an ASD diagnosis in the last 3 months & is waiting for services. Participants receive parent coaching 3x weekly for 9-12 weeks for 30-60 minutes over telehealth. Questionnaires and interviews are given before and after the intervention. Overall, parents commit to 18 months of participation.
• children 1 to 5 years old
• waiting for either Autism Spectrum Disorder (ASD) diagnosis or intervention
• at least one caregiver (approved by the parent) willing to participate
• determined by study staff following review of child's specific behaviors
PIOGLITAZONE-METFORMIN COMBINATION TREATMENT FOR HIGH RISK ORAL PRENEOPLASIA
The purpose of this study is to learn about the safety and effects of pioglitazone and metformin on people and their risk of cancers of the head or neck. We hope to learn more about the potential for pioglitazone and metformin to be used as a way to prevent oral or oropharyngeal cancers in people who are at risk for those cancers. Participants will get both pioglitazone and metformin, as a single pill to be taken at the same time for 12 weeks.
• hyperplasia in high risk areas (floor of mouth, mobile tongue, oropharynx) confirmed by biopsy
• able to swallow a tablet whole
• Body mass index (BMI) is ≥ 18.5
• sexually active persons of child-bearing potential agrees to use adequate contraception
• see link to clinicaltrials.gov for complete inclusion criteria
• women who are pregnant or breastfeeding or planning to become pregnant
• diagnosis of Type I or Type II diabetes that is being treated with insulin or an antidiabetic agent
• history of bladder cancer, including in situ bladder cancer
• history of invasive cancer (other than non-melanoma skin cancer or cervical cancer in situ) in past 18 months
• see link to clinicaltrials.gov for complete exclusion criteria
NEPTUNE: The Nephrotic Syndrome Study Network - RDCRN Protocol 6801 (NEPTUNE)
Nephrotic syndrome is a condition which affects the kidneys causing them to leak protein from the blood into the urine. Nephrotic syndrome is a disease that can improve (remission) and worsen (relapse) at different times throughout childhood. By collecting health information and laboratory samples, our goal is to learn more about these kidney diseases and find better ways to prevent and treat people with nephrotic syndrome. New knowledge will be shared with researchers and the public.
• Group A: up to 80 years of age with clinical diagnosis for FSGS/MCD or MN or pediatric participants who have protein in the urine and are scheduled for a kidney biopsy
• Group B: are less than 19 years old, have started immunosuppression drugs less than 30 days ago and have abnormal kidney lab values
• prior solid organ transplant
• clinical diagnosis of glomerulopathy without diagnostic renal biopsy
• systemic lupus erythematosus (SLE)
• clinical evidence of other renal diseases
Identifying Impairments in Bilateral Coordination in Individuals Post-Stroke
Bilateral coordination (ability to use both arms) is poorly understood in stroke. We are using a robotic device to measure bilateral coordination in different tasks in individuals with chronic stroke and people of the same age who have not had a stroke.
• Chronic stroke diagnosed at least 6 months ago
• at least 45 years old
• experiencing one-sided weakness (Hemiparesis)
• Healthy Participants: at least 45 years old, no known orthopedic or musculoskeletal difficulties
• medical diagnosis of any neurodegenerative disorder.
• unable to move the upper limbs
• unable to follow simple instructions
• any impairments or severe pain that limits the movement of the upper limb
A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients with Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum
We are looking at how well letrozole with or without paclitaxel and carboplatin works in treating patients with stage II-IV low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum. Letrozole is an enzyme inhibitor that lowers the amount of estrogen made by the body and may stop the growth of tumor cells that need estrogen to grow. We will compare the effectiveness of the two different treatments.
• newly diagnosed, stage II-IV low-grade serous ovarian cancer fallopian tube or primary peritoneal cancers
• surgery for maximal cytoreduction completed within 8 weeks of randomization
• bilateral salpingo-oophorectomy completed
• able to take oral medications
• prior neoadjuvant chemotherapy, endocrine therapy or radiotherapy for the treatment of this disease
• severe cardiac disease
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.
• 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
• 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)