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

Official record

Identifier

NCT05287451

Recruiting locations

country

United States

Interventions studied

RIsk-Reducing Salpingectomy (RRS)Risk-Reducing Oophorectomy-RRORisk-Reducing Salpingo-Oophorectomy-RRSO

Lead sponsor

M.D. Anderson Cancer Center

Target enrolment

100 participants

Study type

INTERVENTIONAL

Phase

Not applicable

Status

Recruiting

First posted

Mar 18, 2022

Last updated on the registry

Sep 29, 2026

Age

18 Years

Sex

FEMALE

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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.

   * The highest risk for cancer is mediated by the BRCA mutation. If a patient has multiple mutations, eligibility will be based on BRCA mutation.
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)

   * A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
   * A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy (HRT). However, in the absence of 12 months of amenorrhea, confirmation per the local standard of care can be considered.
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.

Indexed under

Ovarian Cancer