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A Study of Opportunistic Salpingectomy to Prevent Ovarian Cancer
RECRUITINGN/ASponsored by Memorial Sloan Kettering Cancer Center
Actively Recruiting
PhaseN/A
SponsorMemorial Sloan Kettering Cancer Center
Started2024-03-08
Est. completion2028-03-08
Eligibility
Age45 Years+
SexFEMALE
Healthy vol.Accepted
Locations10 sites
View on ClinicalTrials.gov →
NCT06312124
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
Age: 45 Years+Sex: FEMALEHealthy volunteers accepted
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
Conditions2
CancerSurgery
Locations10 sites
Johns Hopkins University (Data Collection Only)
Baltimore, Maryland, 21287
Rebecca Stone, MD410-955-8240
Dana Farber Cancer Institute (Data Collection Only)
Boston, Massachusetts, 02115
Michelle Davis, MD617-732-8840
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Kara Long Roche, MD646-608-3787
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, 07748
Kara Long Roche, MD646-608-3787
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Kara Long Roche, MD646-608-3787
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Actively Recruiting
PhaseN/A
SponsorMemorial Sloan Kettering Cancer Center
Started2024-03-08
Est. completion2028-03-08
Eligibility
Age45 Years+
SexFEMALE
Healthy vol.Accepted
Locations10 sites
View on ClinicalTrials.gov →
NCT06312124