NCT06312124NARecruitingAccepts Healthy Volunteers
A Study of Opportunistic Salpingectomy to Prevent Ovarian Cancer
Memorial Sloan Kettering Cancer Center
Start Date
3/8/2024
Completion Date
3/8/2028
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.
Eligibility Criteria
Age Range: 45 years to No maximum
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
Interventions
BEHAVIORAL
Educational Module
PROCEDURE
Salpingectomy
Conditions
Surgery
Locations
Johns Hopkins University (Data Collection Only)
Baltimore, Maryland 21287
United States
Dana Farber Cancer Institute (Data Collection Only)
Boston, Massachusetts 02115
United States
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey 07920
United States
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey 07748
United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey 07645
United States
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)
Commack, New York 11725
United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York 10604
United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York 10065
United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York 11553
United States
MD Anderson Cancer Center (Data Collection Only)
Houston, Texas 77030
United States