The EDC is live today — see what ships now
All studies
NCT05287451From ClinicalTrials.govRecruiting

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
  • Fallopian Tube Cancer

At a glance

Phase
Phase not stated
Study type
Interventional
Sponsor
M.D. Anderson Cancer Center
Enrolment target
100
Started
10 May 2022
Main results due
26 December 2026
Study sites
9
Registry updated
29 September 2026

Can you take part?

  • Aged 18 years and over.
  • Women only.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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.

What this study is about

In the sponsor’s own words, from the registry.

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

Study sites(9)

  • Dana Farber Cancer Institute

    Boston, Massachusetts, United States

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, United States

    Recruiting

  • WU St Louis

    St Louis, Missouri, United States

    Recruiting

  • Mount Sinai Health System

    New York, New York, United States

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, United States

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, United States

    Recruiting

  • Lyndon Baines Johnson General

    Houston, Texas, United States

    Recruiting

  • M D Anderson Cancer Center

    Houston, Texas, United States

    Recruiting

  • University of Washington

    Seattle, Washington, United States

    Recruiting

Showing 9 of 9 sites. 9 of the 9 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT05287451. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

Not the right study?

Answer three questions and see the studies recruiting near you, in plain language.

Find a study for me
Risk Reducing Salpingectomy With Delayed Oophorectomy as an Alternative to Risk- Reducing Salpingo-oophorectom | Trialion