NCT05287451

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

The aim of the project is to evaluate RRS with delayed RRO as an alternative for RRSO in BRCA1/2 gene germline mutation carriers with respect to ovarian cancer incidence. We hypothesize that postponement of oophorectomy and consequent menopause to the age of 40-45 (BRCA1) or 45-50 (BRCA2) compared to current standard RRSO at age 35-40 (BRCA1) or 40-45 (BRCA2) will not lead to a significant increase in ovarian cancer risk. PRIMARY OBJECTIVE: To 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 in BRCA1/2 gene germline mutation carriers. SECONDARY OBJECTIVE: Incidence of (pre)malignant findings in tubes/ovaries, perioperative morbidity and mortality, incidence of non-ovarian pelvic cancer, breast cancer, prophylactic breast surgery and uptake of risk reducing oophorectomy. EXPLORATORY OBJECTIVE: Estimate high grade serous (ovarian) cancer incidence for innovative and standard treatments in BRIP1, RAD51C, and RAD51D gene germline mutation carriers

Conditions

• Ovarian Cancer
• Fallopian Tube Cancer

Interventions

Type	Name	Description
OTHER	RIsk-Reducing Salpingectomy (RRS)	complete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure
OTHER	Risk-Reducing Oophorectomy-RRO	complete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure
OTHER	Risk-Reducing Salpingo-Oophorectomy-RRSO	complete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure

Timeline

• Start date: 2022-05-10
• Primary completion: 2026-12-26
• Completion: 2026-12-26
• First posted: 2022-03-18
• Last updated: 2026-04-15

Locations

9 sites across 1 country: United States