A Study of Opportunistic Salpingectomy to Prevent Ovarian Cancer
Recruiting now · Not applicable
Conditions studied: Surgery
In brief
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.
Key facts
- Study ID
- NCT06312124
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 266
- Starts
- 2024-03-08
- Expected to finish
- 2028-03-08
- Last updated by the study team
- 2026-06-24
Who can join
Age: 45 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- MD Anderson Cancer Center (Data Collection Only) — Houston, Texas, United States (enrolling)
- Johns Hopkins University (Data Collection Only) — Baltimore, Maryland, United States (enrolling)
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (enrolling)
- Memorial Sloan Kettering Monmouth (Limited protocol activities) — Middletown, New Jersey, United States (enrolling)
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States (enrolling)
- Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities) — Commack, New York, United States (enrolling)
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States (enrolling)
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (enrolling)
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York, United States (enrolling)
- Dana Farber Cancer Institute (Data Collection Only) — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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