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Ovarian CancerNCT05287451

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

A study testing RIsk-Reducing Salpingectomy (RRS), Risk-Reducing Oophorectomy-RRO and Risk-Reducing Salpingo-Oophorectomy-RRSO in people with Ovarian Cancer and Fallopian Tube Cancer, run by M.D. Anderson Cancer Center at 11 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer, Fallopian Tube Cancer
What is being tested?
RIsk-Reducing Salpingectomy (RRS), Risk-Reducing Oophorectomy-RRO and Risk-Reducing Salpingo-Oophorectomy-RRSO
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
11 sitesUnited States
Study dates
10 May 2022to 26 Dec 2026
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • In order to be eligible to participate in this study, a subject must meet all of the following criteria:
  • Premenopausal women with a documented deleterious mutation in BRCA1, BRCA2, BRIP1, RAD51C, PALB2 and/or RAD51D gene germline mutation.
  • 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.
  • No longer requires fallopian tubes for natural childbearing. Future plans for IVF are acceptable.
  • Presence of at least one fallopian tube.
  • Participants may have a personal history of non-ovarian malignancy.
  • Informed consent must be obtained and documented.

Who cannot join

  • A potential subject who meets any of the following criteria will be excluded from participation in this study:
  • 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.
  • Wish for second stage RRO within two years after RRS (if clear at enrollment)
  • Legally incapable
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  • Prior bilateral salpingectomy
  • A personal history of ovarian, fallopian tube, or peritoneal cancer
  • Current clinicals signs, diagnosis, or treatment for malignant disease. Aromatase Inhibitors, Tamoxifen, and Selective Estrogen Receptor Modulators (SERM) are allowed.

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Roni Wilke, MD contact

(713) 822-4502

rnitecki@mdanderson.org

11 sites in 1 country

United States11 sites, 11 recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

    Colleen Feltmate, cfeltmate@bwh.harvard.edu

    Colleen Feltmate

    Recruiting

  • University of Chicago

    Chicago, Illinois, 60637

    Kathryn Mills, MD, kmills6@bsd.uchicago.edu

    Kathryn Mills, MD

    Recruiting

  • Duke University

    Durham, North Carolina, 27708

    Haley Moss, MD, haley.moss@duke.edu

    Haley Moss, MD

    Recruiting

  • Lyndon Baines Johnson General

    Houston, Texas, 77026

    Roni Wilke, MD, rnitechi@mdanderson.org

    Roni Wilke, MD

    Recruiting

  • M D Anderson Cancer Center

    Houston, Texas, 77030

    Roni Wilke, MD, 713-822-4502, rnitecki@mdanderson.org

    Recruiting

  • Mount Sinai Health System

    New York, New York, 10029

    Stephanie Blank, MD, Stephanie.Blank@mountsinai.org

    Stephanie Blank, MD

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Kara Long-Roche, MD, longrock@mskcc.org

    Kara Long-Roche, MD

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Sarah Kim, MD, Sarah.Kim@pennmedicine.upenn.edu

    Sarah Kim, MD

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Jamie N Bakkum-Gamez, MD, bakkum.jamie@mayo.edu

    Jamie N Bakkum-Gamez, MD

    Recruiting

  • University of Washington

    Seattle, Washington, 98195

    Barbara Norquist, MD, bnorquis@uw.edu

    Barbara Norquist, MD

    Recruiting

  • WU St Louis

    St Louis, Missouri, 63130

    Andrea Hagemann, MD

    Andrea Hagemann, MD

    Recruiting

Other trials in United States

About this study

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

Read the 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

Being tested
RIsk-Reducing Salpingectomy (RRS), Risk-Reducing Oophorectomy-RRO, Risk-Reducing Salpingo-Oophorectomy-RRSO
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RIsk-Reducing Salpingectomy (RRS)Other

    complete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure

  • Risk-Reducing Oophorectomy-RROOther

    complete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure

  • Risk-Reducing Salpingo-Oophorectomy-RRSOOther

    complete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure

Study groups in NCT05287451
Study groupRoleWhat they receive
Risk-Reducing Salpingectomy-RRSOtherCan help to lower the risk of ovarian cancer with a delayed removal of 1.
Receives: Other: RIsk-Reducing Salpingectomy (RRS)
Risk-Reducing Oophorectomy-RROOtherCan help to lower the risk of ovarian cancer removing both fallopian tubes.
Receives: Other: Risk-Reducing Oophorectomy-RRO
Risk-Reducing Salpingo-Oophorectomy-RRSOOtherCan 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)
Receives: Other: Risk-Reducing Salpingo-Oophorectomy-RRSO

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: through study completion, an average of 15 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2022
  2. Study start10 May 2022
  3. Primary completion26 Dec 2026 (estimated)
  4. Study completion26 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05287451
Sponsor's protocol ID
2021-1089
Other IDs
NCI-2022-01291
Status last verified
Oct 2026
First submitted
7 Feb 2022
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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