A Study of Opportunistic Salpingectomy to Prevent Ovarian Cancer

Not Applicable

Recruiting

• Conditions: Surgery
• Interventions: Behavioral: Educational Module; Procedure: Salpingectomy

• Registration Number: NCT06312124
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-08
• Study First Submitted: 2024-03-08
• Study First Submitted QC: 2024-03-08
• Study First Posted: 2024-03-15
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22
• Primary Completion: 2028-03-08
• Study Completion: 2028-03-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Participants scheduled for non-gynecologic abdominopelvic surgery	Salpingectomy	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.
Participants scheduled for non-gynecologic abdominopelvic surgery	Educational Module	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.

Primary Outcome Measures

Name	Time	Method
Rate of Opportunistic Salpingectomy/OS after completion of educational module	up to 2 years	Evaluate the acceptance of Opportunistic Salpingectomy/OS among nongynecologic surgical patients after completion of an educational module

Trial Locations

Locations (10)

Johns Hopkins University (Data Collection Only); 🇺🇸 Baltimore, Maryland, United States

Dana Farber Cancer Institute (Data Collection Only); 🇺🇸 Boston, Massachusetts, United States

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited protocol activities); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities); 🇺🇸 Uniondale, New York, United States

MD Anderson Cancer Center (Data Collection Only); 🇺🇸 Houston, Texas, United States