Preventing ovarian cancer through a surgical procedure after education
A Multi-Disciplinary Approach to the Opportunistic Salpingectomy for Primary Prevention of Ovarian Cancer
This study is testing if showing an educational video can help people aged 45 and older decide if they want to have a surgery that may lower their risk of ovarian cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 266 (estimated) |
| Ages | 45 Years and up |
| Sex | Female |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Locations | 10 sites (Baltimore, Maryland and 9 other locations) |
| Trial ID | NCT06312124 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the interest of participants in undergoing an opportunistic salpingectomy, a surgical procedure intended to reduce the risk of ovarian cancer, after viewing an educational video. Participants aged 45 and older, who are scheduled for a visit with a nongynecologic surgeon, will complete questionnaires before and after watching the video to gauge their interest in the procedure. The study will involve multiple locations, including Memorial Sloan Kettering Cancer Center and other collaborating institutions, to gather data on patient preferences and decision-making regarding this preventive surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 45 and older who are scheduled for non-gynecologic surgery and have an average risk of developing ovarian cancer.
Not a fit: Patients who are not fluent in English or those who wish to have children in the future may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to increased awareness and uptake of a preventive surgical option that may significantly reduce the risk of ovarian cancer in eligible patients.
How similar studies have performed: Other studies have explored similar preventive surgical approaches, indicating potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Baltimore, Maryland and 9 other locations
- Johns Hopkins University (Data Collection Only) — Baltimore, Maryland, United States (Recruiting)
- Dana Farber Cancer Institute (Data Collection Only) — Boston, Massachusetts, United States (Not_yet_recruiting)
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (Limited protocol activities) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York, United States (Recruiting)
- MD Anderson Cancer Center (Data Collection Only) — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Kara Long Roche, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Kara Long Roche, MD
- Email: longrock@mskcc.org
- Phone: 212-639-7043
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.