A Study of Opportunistic Salpingectomy to Prevent Ovarian Cancer

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

Conditions: Surgery

Treatments: Behavioral: Educational Module; Procedure: Salpingectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06312124

24-006

Details and patient eligibility

About

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.

Enrollment: 266 estimated patients

Sex: Female

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

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 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.
• Procedures with palliative intent only

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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266 participants in 1 patient group

Participants scheduled for non-gynecologic abdominopelvic surgery

Experimental group

Description:

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.

Treatment:

Procedure: Salpingectomy

Behavioral: Educational Module