Clinical trial NCT06312124: A Study of Opportunistic Salpingectomy to Prevent Ovarian Cancer
Official title: A Multi-Disciplinary Approach to the Opportunistic Salpingectomy for Primary Prevention of Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Surgery
Keywords: abdominal surgery
pelvic surgery
Opportunistic Salpingectomy
ovarian cancer prevention
24-006
Memorial Sloan Kettering Cancer Center
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 400
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief 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 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

  ° If there is a non-english 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
* 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

Primary outcomes:
measure: Rate of Opportunistic Salpingectomy/OS after completion of educational module
timeFrame: up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University (Data Collection Only)
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Institute (Data Collection Only)
state: Massachusetts
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Limited protocol activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities)
state: New York
city: Houston
country: United States
facility: MD Anderson Cancer Center (Data Collection Only)
state: Texas
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Kara Long Roche, MD
role: PRINCIPAL_INVESTIGATOR
References: