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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05287451
• Other study ID #: 2021-1089
• Secondary ID: NCI-2022-01291
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2022
• Est. completion date: December 26, 2026

Study information

• Verified date: June 2024
• Source: M.D. Anderson Cancer Center
• Contact: Karen Lu, MD
• Phone: (713) 745-8902
• Email: khlu[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 26, 2026
• Est. primary completion date: December 26, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

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

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer

Intervention

Other:
• RIsk-Reducing Salpingectomy (RRS)
complete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure
• Risk-Reducing Oophorectomy-RRO
complete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure
• Risk-Reducing Salpingo-Oophorectomy-RRSO
complete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure

Locations

Country	Name	City	State
United States	Harvard Cancer Center	Boston	Massachusetts
United States	M D Anderson Cancer Center	Houston	Texas
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Fred Hutch/University of Washington/Seattle Children's Cancer Consortium	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   M D Anderson Cancer Center