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 (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05287451
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 55.6
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer; Fallopian Tube Cancer	Other: RIsk-Reducing Salpingectomy (RRS); Other: Risk-Reducing Oophorectomy-RRO; Other: Risk-Reducing Salpingo-Oophorectomy-RRSO	N/A

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: May 10, 2022
• Anticipated Primary Completion Date: Dec 26, 2026
• Anticipated Study Completion Date: Dec 26, 2026

Arms and Interventions

Arm	Intervention/Treatment
Other: Risk-Reducing Salpingectomy-RRS Can help to lower the risk of ovarian cancer with a delayed removal of 1.	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 Can help to lower the risk of ovarian cancer removing both fallopian tubes.	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 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)	Other: Risk-Reducing Salpingo-Oophorectomy-RRSO; complete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure

Outcome Measures

Primary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Premenopausal women with a documented deleterious mutation in BRCA1, BRCA2, BRIP1, RAD51C and/or RAD51D gene germline mutation.

• Age 25-40 years for BRCA1 mutation carriers, 25-45 years for BRCA2 and 30-50 yearsfor BRIP1, RAD51C, RAD51D

• Childbearing completed

• Presence of at least one fallopian tube

• Participants may have a personal history of non-ovarian malignancy

• Informed consent must be obtained and documented.

Exclusion Criteria:

Postmenopausal status (natural menopause or due to (cancer) treatment)

• Wish for second stage RRO within two years after RRS (if clear at enrollment)

• Legally incapable

• Prior bilateral salpingectomy

• A personal history of ovarian, fallopian tube or peritoneal cancer

• Current clinical signs, diagnosis or treatment for malignant disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	M D Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• M.D. Anderson Cancer Center

Investigators

• Principal Investigator: Karen Lu, MD, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• M D Anderson Cancer Center

Publications

None provided.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT05287451
• Other Study ID Numbers: 2021-1089
• First Posted: Mar 18, 2022
• Last Update Posted: May 11, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Fallopian Tube Neoplasms

Study Results

No Results Posted as of May 11, 2022