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

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Fallopian Tube Cancer; Ovarian Cancer

Treatments: Other: Risk-Reducing Salpingo-Oophorectomy-RRSO; Other: RIsk-Reducing Salpingectomy (RRS); Other: Risk-Reducing Oophorectomy-RRO

Study type: Interventional

Funder types: Other

Identifiers

NCT05287451

NCI-2022-01291 (Other Identifier)

2021-1089

Details and patient eligibility

About

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

Full 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

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

1. Premenopausal women with a documented deleterious mutation in BRCA1, BRCA2, BRIP1, RAD51C, PALB2 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, and PALB2
3. No longer requires fallopian tubes for natural childbearing. Future plans for IVF are acceptable
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

A potential subject who meets any of the following criteria will be excluded from participation in this study:

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. Aromatase Inhibitors, Tamoxifen, and Selective Estrogen Receptor Modulators (SERM) are allowed.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

Risk-Reducing Salpingectomy-RRS

Other group

Description:

Can help to lower the risk of ovarian cancer with a delayed removal of 1.

Treatment:

Other: RIsk-Reducing Salpingectomy (RRS)

Risk-Reducing Oophorectomy-RRO

Other group

Description:

Can help to lower the risk of ovarian cancer removing both fallopian tubes.

Treatment:

Other: Risk-Reducing Oophorectomy-RRO

Risk-Reducing Salpingo-Oophorectomy-RRSO

Other group

Description:

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)

Treatment:

Other: Risk-Reducing Salpingo-Oophorectomy-RRSO