A Study of Opportunistic Salpingectomy to Prevent Ovarian Cancer

Last updated: May 19, 2025
Sponsor: Memorial Sloan Kettering Cancer Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Surgery

Ovarian Cysts

Treatment

Educational Module

Salpingectomy

Clinical Study ID

NCT06312124
24-006
  • Ages > 45
  • Female
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to find out how many participants are interested in a surgical preventive procedure after watching an educational video. Before and after watching the video, participants will complete questionnaires in the clinic.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Part I

  • Age ≥45 years

  • Scheduled visit with a nongynecologic surgeon

  • Female or assigned female at birth

Part II

  • Age ≥45 years

  • At least one in situ fallopian tube

  • No desire or plan to have children in the future

  • Average risk of developing ovarian cancer

° Note: Average risk patients are defined as patients with no known genetic riskfactor for developing ovarian cancer. Patients who, after obtaining family history,are suspected to have a hereditary ovarian cancer syndrome but have not yet beentested, will be referred for genetic evaluation.

  • Planned nongynecologic, intraabdominal, or pelvic surgery

  • Deemed to be a suitable candidate by gynecologic surgeon and primary nongynecologicsurgeon (for example, on the basis of surgical history and current malignancystatus)

  • Approved and signed informed consent

Exclusion

Exclusion Criteria:

Part I

  • Not fluent in English

° If there is a non-english speaking participant who is a strong candidate and meetsall other criteria for Part 2, they are able to go directly onto Part 2 withoutcompleting Part 1. (Please see additional details in section 4.1 and 7.0.)

  • Known inherited ovarian cancer susceptibility

Part II

  • Personal history of a gynecologic malignancy

  • Carrier of a hereditary breast or ovarian cancer variant (e.g., BRCA1, BRCA2, BRIP1,PALB2, RAD51C, RAD51D, MLH1, MSH2, MSH6, PMS2)

  • Suspicious ovarian, fallopian tube, or uterine lesion on preoperative imaging

  • Previous bilateral salpingectomy or bilateral salpingo-oophorectomy

  • Current pregnancy

  • Emergent procedure or emergency procedure that has to be completed within 24 hourswhere clinical consent occurs in the inpatient setting or where the patient'simmediate well-being is in danger or condition may be life threatening

  • Primary surgeon anticipates that OS will add significant time (>30-40min) to theplanned procedure.

  • Inability to access the pelvis (ex., patient prone/lateral position) during theplanned procedure.

  • Known history of pelvic fibrosis or significant adhesions.

  • Procedures with palliative intent only

Study Design

Total Participants: 400
Treatment Group(s): 2
Primary Treatment: Educational Module
Phase:
Study Start date:
March 08, 2024
Estimated Completion Date:
March 08, 2028

Connect with a study center

  • Johns Hopkins University (Data Collection Only)

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Dana Farber Cancer Institute (Data Collection Only)

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey 07920
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Monmouth (Limited protocol activities)

    Middletown, New Jersey 07748
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey 07645
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)

    Commack, New York 11725
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York 10604
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York 10065
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Uniondale, New York 11553
    United States

    Active - Recruiting

  • MD Anderson Cancer Center (Data Collection Only)

    Houston, Texas 77030
    United States

    Site Not Available

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