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Trial Title: A Study of Opportunistic Salpingectomy to Prevent Ovarian Cancer

NCT ID: NCT06312124

Condition: Surgery

Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial

Conditions: Keywords:
abdominal surgery
pelvic surgery
Opportunistic Salpingectomy
ovarian cancer prevention
24-006
Memorial Sloan Kettering Cancer Center

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Sequential Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Educational Module
Description: Part 1 consists of an education module with premodule and postmodule assessment questionnaires.
Arm group label: Participants scheduled for non-gynecologic abdominopelvic surgery

Intervention type: Procedure
Intervention name: Salpingectomy
Description: Part 2 consists of incorporating opportunistic salpingectomy /OS into non-gynecologic surgery
Arm group label: Participants scheduled for non-gynecologic abdominopelvic surgery

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.

Criteria for 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

Gender: Female

Minimum age: 45 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Johns Hopkins University (Data Collection Only)

Address:
City: Baltimore
Zip: 21287
Country: United States

Status: Not yet recruiting

Contact:
Last name: Rebecca Stone, MD

Phone: 410-955-8240

Facility:
Name: Dana Farber Cancer Institute (Data Collection Only)

Address:
City: Boston
Zip: 02115
Country: United States

Status: Not yet recruiting

Contact:
Last name: Michelle Davis, MD

Phone: 617-732-8840

Facility:
Name: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Address:
City: Basking Ridge
Zip: 07920
Country: United States

Status: Recruiting

Contact:
Last name: Kara Long Roche, MD

Phone: 646-608-3787

Facility:
Name: Memorial Sloan Kettering Monmouth (Limited protocol activities)

Address:
City: Middletown
Zip: 07748
Country: United States

Status: Recruiting

Contact:
Last name: Kara Long Roche, MD

Phone: 646-608-3787

Facility:
Name: Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Address:
City: Montvale
Zip: 07645
Country: United States

Status: Recruiting

Contact:
Last name: Kara Long Roche, MD

Phone: 646-608-3787

Facility:
Name: Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)

Address:
City: Commack
Zip: 11725
Country: United States

Status: Recruiting

Contact:
Last name: Kara Long Roche, MD

Phone: 646-608-3787

Facility:
Name: Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Address:
City: Harrison
Zip: 10604
Country: United States

Status: Recruiting

Contact:
Last name: Kara Long Roche, MD

Phone: 646-608-3787

Facility:
Name: Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Address:
City: New York
Zip: 10065
Country: United States

Status: Recruiting

Contact:
Last name: Kara Long Roche, MD

Phone: 646-608-3787

Facility:
Name: Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Address:
City: Uniondale
Zip: 11553
Country: United States

Status: Recruiting

Contact:
Last name: Kara Long Roche, MD

Phone: 646-608-3787

Facility:
Name: MD Anderson Cancer Center (Data Collection Only)

Address:
City: Houston
Zip: 77030
Country: United States

Status: Not yet recruiting

Contact:
Last name: Karen Lu, MD

Phone: 713-745-8902

Start date: March 8, 2024

Completion date: March 8, 2028

Lead sponsor:
Agency: Memorial Sloan Kettering Cancer Center
Agency class: Other

Source: Memorial Sloan Kettering Cancer Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06312124
http://www.mskcc.org

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