A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer (NCT04251052)

🧪 Interventions in This Study

• Bilateral Salpingectomy (PROCEDURE)
• Bilateral Salpingectomy with Oophorectomy (PROCEDURE)
• Biospecimen Collection (PROCEDURE)
• Magnetic Resonance Imaging (PROCEDURE)
• Quality-of-Life Assessment (OTHER)
• Questionnaire Administration (OTHER)
• Transvaginal Ultrasound (PROCEDURE)
• Ultrasound Imaging (PROCEDURE)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Individuals 35-50 years of age, inclusive
2. Patients who will undergo risk-reducing salpingo-oophorectomy (RRSO) (for the BSO arm) and patients who have declined or elected to defer BSO after proper counselling to clearly explain the standard of care for BRCA1 mutation carriers and are undergoing salpingectomy (for the BLS arm with delayed oophorectomy arm). Concurrently planned hysterectomy with either arm is permitted
3. At least one intact ovary and fallopian tube is in situ at the time of counseling, consent, and registration. Prior hysterectomy is allowed provided it did not include bilateral salpingectomy. Prior tubal ligation is allowed if one ovary and fallopian tube (with fimbria not removed) are present
4. Positive Clinical Laboratory Improvement Act (CLIA)-approved test results for pathogenic or likely pathogenic germline BRCA1 mutation in the patient. Documentation of the result is required
5. Patients may be premenopausal or menopausal
6. Pelvic ultrasound (transvaginal imaging preferred, but transabdominal imaging is acceptable) or pelvic MRI and CA-125 within 180 days of registration
7. The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
8. Individuals who are currently pregnant or plan to become pregnant in the future through assisted reproductive technologies and who have received proper counseling are eligible. Individuals who are currently pregnant and plan bilateral salpingectomy at the time of a planned cesarean section are eligible. Patients must understand that they will not be able to become pregnant naturally in the future

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (574 Sites)

Showing the first 25 of 574 sites.

• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama
• Anchorage Associates in Radiation Medicine — Anchorage, Alaska
• Anchorage Radiation Therapy Center — Anchorage, Alaska
• Alaska Breast Care and Surgery LLC — Anchorage, Alaska
• Alaska Oncology and Hematology LLC — Anchorage, Alaska
• Alaska Women's Cancer Care — Anchorage, Alaska
• Katmai Oncology Group — Anchorage, Alaska
• Providence Alaska Medical Center — Anchorage, Alaska
• CTCA at Western Regional Medical Center — Goodyear, Arizona
• Banner University Medical Center - Tucson — Tucson, Arizona
• University of Arizona Cancer Center-North Campus — Tucson, Arizona
• University of Arkansas for Medical Sciences — Little Rock, Arkansas
• Kaiser Permanente-Deer Valley Medical Center — Antioch, California
• Tower Cancer Research Foundation — Beverly Hills, California
• Keck Medicine of USC Buena Park — Buena Park, California
• Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California
• Mercy Cancer Center - Carmichael — Carmichael, California
• Mercy San Juan Medical Center — Carmichael, California
• City of Hope Comprehensive Cancer Center — Duarte, California
• Kaiser Permanente Dublin — Dublin, California
• Mercy Cancer Center - Elk Grove — Elk Grove, California
• Kaiser Permanente-Fremont — Fremont, California
• Fresno Cancer Center — Fresno, California
• Kaiser Permanente Fresno Orchard Plaza — Fresno, California
• Kaiser Permanente-Fresno — Fresno, California

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Ovarian Carcinoma

• Adapted Helping Ovarian Cancer Patients Cope Intervention to Address Burnout for Gynecologic Oncology Clinicians — Seattle, Washington
• Prophylactic Salpingectomy With Delayed Oophorectomy — Evanston, Illinois
• Dietary Magnesium in Preventing Low Blood Magnesium Levels in Patients With Ovarian Cancer Receiving Carboplatin Chemotherapy — Houston, Texas
• A Study of Sacituzumab Govitecan (IMMU-132) in Platinum-resistant Ovarian Cancer Patients — New Haven, Connecticut
• Screening for Ovarian Cancer in Older Patients (PLCO Screening Trial) — Bethesda, Maryland

Explore by condition: All Ovarian Carcinoma clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.