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

Not Applicable

Recruiting

• Conditions: Ovarian Cancer; Fallopian Tube Cancer

• Registration Number: NCT05287451
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-2-7
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Premenopausal women with a documented deleterious mutation in BRCA1, BRCA2, BRIP1,<br> RAD51C and/or RAD51D gene germline mutation.<br><br> 2. Age 25-40 years for BRCA1 mutation carriers, 25-45 years for BRCA2 and 30-50 years<br> for BRIP1, RAD51C, RAD51D<br><br> 3. Childbearing completed or no longer requires fallopian tubes<br><br> 4. Presence of at least one fallopian tube<br><br> 5. Participants may have a personal history of non-ovarian malignancy.<br><br> 6. Informed consent must be obtained and documented.<br><br>Exclusion Criteria:<br><br> 1. Postmenopausal status (natural menopause or due to (cancer) treatment)<br><br> 2. Wish for second stage RRO within two years after RRS (if clear at enrollment)<br><br> 3. Legally incapable<br><br> 4. Prior bilateral salpingectomy<br><br> 5. A personal history of ovarian, fallopian tube or peritoneal cancer<br><br> 6. Current clinicals signs, diagnosis or treatment for malignant disease

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the 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 in BRCA1/2 gene germline mutation carriers.