A Study of Opportunistic Salpingectomy to Prevent Ovarian Cancer (NCT06312124) | Clinical Trial Compass
RecruitingNot Applicable
A Study of Opportunistic Salpingectomy to Prevent Ovarian Cancer
United States266 participantsStarted 2024-03-08
Plain-language 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.
Who can participate
Age range45 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
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What they're measuring
1
Rate of Opportunistic Salpingectomy/OS after completion of educational module