NCT06312124

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
266

participants targeted

Target at P75+ for not_applicable surgery

Timeline
23mo left

Started Mar 2024

Longer than P75 for not_applicable surgery

Geographic Reach
1 country

10 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Mar 2024Mar 2028

First Submitted

Initial submission to the registry

March 8, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

March 8, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2028

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

4 years

First QC Date

March 8, 2024

Last Update Submit

January 21, 2026

Conditions

Surgery

Keywords

abdominal surgerypelvic surgeryOpportunistic Salpingectomyovarian cancer prevention24-006Memorial Sloan Kettering Cancer Center

Outcome Measures

Primary Outcomes (1)

  • Rate of Opportunistic Salpingectomy/OS after completion of educational module

    Evaluate the acceptance of Opportunistic Salpingectomy/OS among nongynecologic surgical patients after completion of an educational module

    up to 2 years

Study Arms (1)

Participants scheduled for non-gynecologic abdominopelvic surgery

EXPERIMENTAL

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 ModuleProcedure: Salpingectomy

Interventions

Educational ModuleBEHAVIORAL

Part 1 consists of an education module with premodule and postmodule assessment questionnaires.

Participants scheduled for non-gynecologic abdominopelvic surgery
SalpingectomyPROCEDURE

Part 2 consists of incorporating opportunistic salpingectomy /OS into non-gynecologic surgery

Participants scheduled for non-gynecologic abdominopelvic surgery

Eligibility Criteria

Age45 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Part I
  • Not fluent in English or Spanish
  • ° If there is a non-english or non-spanish 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
  • Presence of ESSURE, or other tubal-implanted birth control at the time of surgery
  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Johns Hopkins University (Data Collection Only)

Baltimore, Maryland, 21287, United States

RECRUITING

Dana Farber Cancer Institute (Data Collection Only)

Boston, Massachusetts, 02115, United States

NOT YET RECRUITING

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

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

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

RECRUITING

MD Anderson Cancer Center (Data Collection Only)

Houston, Texas, 77030, United States

RECRUITING

Related Links

MeSH Terms

Interventions

Salpingectomy

Intervention Hierarchy (Ancestors)

Gynecologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Kara Long Roche, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kara Long Roche, MD

CONTACT

212-639-7043longrock@mskcc.org

Martin Weiser, MD

CONTACT

212-639-6698weiser1@mskcc.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2024

First Posted

March 15, 2024

Study Start

March 8, 2024

Primary Completion (Estimated)

March 8, 2028

Study Completion (Estimated)

March 8, 2028

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

• 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.

Locations

US(10)