A Study of Opportunistic Salpingectomy to Prevent Ovarian Cancer

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06312124
• Other study ID #: 24-006
• Status: Recruiting
• Phase: N/A
• Start date: March 8, 2024
• Est. completion date: March 8, 2028

Study information

• Verified date: March 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Kara Long Roche, MD
• Phone: 212-639-7043
• Email: longrock[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: March 8, 2028
• Est. primary completion date: March 8, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Neoplasms
• Surgery

Intervention

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

Locations

Country	Name	City	State
United States	Johns Hopkins University (Data Collection Only)	Baltimore	Maryland
United States	Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)	Basking Ridge	New Jersey
United States	Dana Farber Cancer Institute (Data Collection Only)	Boston	Massachusetts
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	MD Anderson Cancer Center (Data Collection Only)	Houston	Texas
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 (All Protocol Activities)	New York	New York
United States	Memorial Sloan Kettering Nassau (Limited Protocol Activities)	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center