Recruiting

Salpingectomy & Oophorectomy

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT05287451

Conditions

Ovarian Cancer

Fallopian Tube Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RIsk-Reducing Salpingectomy (RRS)

Risk-Reducing Oophorectomy-RRO

Risk-Reducing Salpingo-Oophorectomy-RRSO

Study Details

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

Conditions

Ovarian Cancer

Fallopian Tube Cancer

Study ID

NCT05287451

Start date

May 10, 2022

Status verified date

Jun, 2026

Completion date

Dec 26, 2026

Anticipated

Primary completion date

Dec 26, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

other: Risk-Reducing Salpingectomy-RRS

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

other: Risk-Reducing Oophorectomy-RRO

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

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)

Interventions

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

Primary outcome measure

  • 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. [ Time Frame: through study completion, an average of 15 years ]

Central Contacts and Locations

Central contacts

Locations

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Principal Investigator:

Colleen Feltmate

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Jamie N Bakkum-Gamez, MD

bakkum.jamie@mayo.edu

Principal Investigator:

Jamie N Bakkum-Gamez, MD

WU St Louis

Recruiting

St Louis, Missouri, United States, 63130

Principal Investigator:

Andrea Hagemann, MD

Mount Sinai Health System

Recruiting

New York, New York, United States, 10029

Contacts

Principal Investigator:

Stephanie Blank, MD

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Kara Long-Roche, MD

longrock@mskcc.org

Principal Investigator:

Kara Long-Roche, MD

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Principal Investigator:

Sarah Kim, MD

Lyndon Baines Johnson General

Recruiting

Houston, Texas, United States, 77026

Contacts

Principal Investigator:

Roni Wilke, MD

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

Barbara Norquist, MD

bnorquis@uw.edu

Principal Investigator:

Barbara Norquist, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-06-26.