A Study of Opportunistic Salpingectomy to Prevent Ovarian Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Educational Module, Salpingectomy.
- Who it may be relevant to
- Registry conditions: Surgery. Basic parameters: from 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multi-Disciplinary Approach to the Opportunistic Salpingectomy for Primary Prevention of Ovarian Cancer
Overview
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.
Interventions
- 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
Primary outcome measures
- Rate of Opportunistic Salpingectomy/OS after completion of educational module [Time frame: up to 2 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 10 centers
- Johns Hopkins University (Data Collection Only) — Baltimore
- Dana Farber Cancer Institute (Data Collection Only) — Boston
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge
- Memorial Sloan Kettering Monmouth (Limited protocol activities) — Middletown
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale
- Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities) — Commack
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
- … and 2 more centers
Identifiers
NCT: NCT06312124 · 24-006