RecruitingNot ApplicableNCT05287451

Risk Reducing Salpingectomy With Delayed Oophorectomy as an Alternative to Risk- Reducing Salpingo-oophorectomy in High Risk-Women to Assess the Safety of Prevention - US Cohort Study


Sponsor

M.D. Anderson Cancer Center

Enrollment

100 participants

Start Date

May 10, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective preference study that will evaluate non-inferiority of the innovative treatment (RRS with delayed RRO) as compared to the standard treatment (RRSO) with respect to high grade serous (ovarian) cancer incidence


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study offers premenopausal women with high-risk gene mutations (such as BRCA1, BRCA2, and related genes) an alternative to the standard preventive surgery of removing both the ovaries and fallopian tubes at once. Instead, they can choose to have only the fallopian tubes removed first (to reduce ovarian cancer risk) and delay removal of the ovaries until later, preserving hormonal function for longer. **You may be eligible if...** - You are a premenopausal woman aged 25–50 (age range varies by mutation type) - You carry a confirmed harmful mutation in BRCA1, BRCA2, BRIP1, RAD51C, RAD51D, or PALB2 - You no longer want to use your fallopian tubes for natural conception (IVF plans are still allowed) - You still have at least one fallopian tube **You may NOT be eligible if...** - You are already postmenopausal - You have a personal history of ovarian, fallopian tube, or peritoneal cancer - You have had a bilateral salpingectomy (both fallopian tubes already removed) - You are legally unable to provide consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERRIsk-Reducing Salpingectomy (RRS)

complete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure

OTHERRisk-Reducing Oophorectomy-RRO

complete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure

OTHERRisk-Reducing Salpingo-Oophorectomy-RRSO

complete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure


Locations(9)

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

WU St Louis

St Louis, Missouri, United States

Mount Sinai Health System

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Lyndon Baines Johnson General

Houston, Texas, United States

M D Anderson Cancer Center

Houston, Texas, United States

University of Washington

Seattle, Washington, United States

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NCT05287451


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