RecruitingRecruiting
A Study of Opportunistic Salpingectomy to Prevent Ovarian Cancer
NCT06312124 · Memorial Sloan Kettering Cancer Center
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
A Multi-Disciplinary Approach to the Opportunistic Salpingectomy for Primary Prevention of Ovarian Cancer
About this study
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.
Eligibility criteria
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
Study design
Enrollment target: 266 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-03-08
Estimated completion: 2028-03-08
Last updated: 2026-06-24
Interventions
Behavioral: Educational ModuleProcedure: Salpingectomy
Primary outcomes
- • Rate of Opportunistic Salpingectomy/OS after completion of educational module (up to 2 years)
Sponsor
Memorial Sloan Kettering Cancer Center · other
Contacts & investigators
ContactKara Long Roche, MD · contact · longrock@mskcc.org · 212-639-7043
ContactMartin Weiser, MD · contact · weiser1@mskcc.org · 212-639-6698
InvestigatorKara Long Roche, MD · principal_investigator, Memorial Sloan Kettering Cancer Center
All locations (10)
Johns Hopkins University (Data Collection Only)Recruiting
Baltimore, Maryland, United States
Dana Farber Cancer Institute (Data Collection Only)Not Yet Recruiting
Boston, Massachusetts, United States
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Recruiting
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Limited protocol activities)Recruiting
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)Recruiting
Montvale, New Jersey, United States
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)Recruiting
Commack, New York, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)Recruiting
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting
New York, New York, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)Recruiting
Uniondale, New York, United States
MD Anderson Cancer Center (Data Collection Only)Recruiting
Houston, Texas, United States