A Study of Opportunistic Salpingectomy to Prevent Ovarian Cancer

March 8, 2024 updated by: Memorial Sloan Kettering Cancer Center

A Multi-Disciplinary Approach to the Opportunistic Salpingectomy for Primary Prevention of Ovarian Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Not yet recruiting
        • Johns Hopkins University (Data Collection Only)
        • Contact:
          • Rebecca Stone, MD
          • Phone Number: 410-955-8240
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Not yet recruiting
        • Dana Farber Cancer Institute (Data Collection Only)
        • Contact:
          • Michelle Davis, MD
          • Phone Number: 617-732-8840
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
        • Contact:
          • Kara Long Roche, MD
          • Phone Number: 646-608-3787
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth (Limited protocol activities)
        • Contact:
          • Kara Long Roche, MD
          • Phone Number: 646-608-3787
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen (Limited Protocol Activities)
        • Contact:
          • Kara Long Roche, MD
          • Phone Number: 646-608-3787
    • New York
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)
        • Contact:
          • Kara Long Roche, MD
          • Phone Number: 646-608-3787
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester (Limited Protocol Activities)
        • Contact:
          • Kara Long Roche, MD
          • Phone Number: 646-608-3787
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
        • Contact:
          • Kara Long Roche, MD
          • Phone Number: 646-608-3787
      • Uniondale, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau (Limited Protocol Activities)
        • Contact:
          • Kara Long Roche, MD
          • Phone Number: 646-608-3787
    • Texas
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • MD ANDERSON CANCER CENTER (Data Collection Only)
        • Contact:
          • Karen Lu, MD
          • Phone Number: 713-745-8902

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 risk factor for developing ovarian cancer. Patients who, after obtaining family history, are suspected to have a hereditary ovarian cancer syndrome but have not yet been tested, will be referred for genetic evaluation.

  • Planned nongynecologic, intraabdominal, or pelvic surgery
  • Deemed to be a suitable candidate by gynecologic surgeon and primary nongynecologic surgeon (for example, on the basis of surgical history and current malignancy status)
  • Approved and signed informed consent

Exclusion Criteria:

Part I

  • Not fluent in English

    ° If there is a non-english speaking participant who is a strong candidate and meets all other criteria for Part 2, they are able to go directly onto Part 2 without completing 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 hours where clinical consent occurs in the inpatient setting or where the patient's immediate well-being is in danger or condition may be life threatening
  • Primary surgeon anticipates that OS will add significant time (>30-40min) to the planned procedure.
  • Inability to access the pelvis (ex., patient prone/lateral position) during the planned procedure.
  • Known history of pelvic fibrosis or significant adhesions.
  • Procedures with palliative intent only

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants scheduled for non-gynecologic abdominopelvic surgery
Participants will be aged ≥45 years, have at least 1 fallopian tube, will not desire or plan to have children in the future, and will be scheduled to undergo non-gynecologic abdominopelvic surgery.
Behavioral: Educational Module
Part 1 consists of an education module with premodule and postmodule assessment questionnaires.
Procedure: Salpingectomy
Part 2 consists of incorporating opportunistic salpingectomy /OS into non-gynecologic surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Opportunistic Salpingectomy/OS after completion of educational module
Time Frame: up to 2 years
Evaluate the acceptance of Opportunistic Salpingectomy/OS among nongynecologic surgical patients after completion of an educational module
up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Kara Long Roche, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2024

Primary Completion (Estimated)

March 8, 2028

Study Completion (Estimated)

March 8, 2028

Study Registration Dates

First Submitted

March 8, 2024

First Submitted That Met QC Criteria

March 8, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

• Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Surgery

Clinical Trials on Educational Module

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe