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: Fallopian Tube Cancer; Ovarian Cancer
• Interventions: Other: Risk-Reducing Salpingo-Oophorectomy-RRSO; Other: RIsk-Reducing Salpingectomy (RRS); Other: Risk-Reducing Oophorectomy-RRO

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

Brief 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-02-07
• Study First Submitted QC: 2022-03-10
• Study First Posted: 2022-03-18
• Study Start: 2022-05-10
• Status Verified: 2024-06
• Last Update Submitted: 2024-08-23
• Last Update Posted: 2024-08-26
• Primary Completion: 2026-12-26
• Study Completion: 2026-12-26

Recruitment & Eligibility

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

Inclusion Criteria

1. Premenopausal women with a documented deleterious mutation in BRCA1, BRCA2, BRIP1, RAD51C and/or RAD51D gene germline mutation.
2. Age 25-40 years for BRCA1 mutation carriers, 25-45 years for BRCA2 and 30-50 years for BRIP1, RAD51C, RAD51D
3. Childbearing completed or no longer requires fallopian tubes
4. Presence of at least one fallopian tube
5. Participants may have a personal history of non-ovarian malignancy.
6. Informed consent must be obtained and documented.

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Exclusion Criteria

1. Postmenopausal status (natural menopause or due to (cancer) treatment)
2. Wish for second stage RRO within two years after RRS (if clear at enrollment)
3. Legally incapable
4. Prior bilateral salpingectomy
5. A personal history of ovarian, fallopian tube or peritoneal cancer
6. Current clinicals signs, diagnosis or treatment for malignant disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Risk-Reducing Salpingo-Oophorectomy-RRSO	Risk-Reducing Salpingo-Oophorectomy-RRSO	Can help to lower the risk of ovarian cancer as well as the standard-of-care risk-reducing procedure involving the removal of the fallopian tubes and ovaries (risk-reducing salpingo-oophorectomy-RRSO)
Risk-Reducing Salpingectomy-RRS	RIsk-Reducing Salpingectomy (RRS)	Can help to lower the risk of ovarian cancer with a delayed removal of 1.
Risk-Reducing Oophorectomy-RRO	Risk-Reducing Oophorectomy-RRO	Can help to lower the risk of ovarian cancer removing both fallopian tubes.

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.	through study completion, an average of 1 year

Trial Locations

Locations (4)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

Harvard Cancer Center; 🇺🇸 Boston, Massachusetts, United States

Fred Hutch/University of Washington/Seattle Children's Cancer Consortium; 🇺🇸 Seattle, Washington, United States