RECRUITING

A Study of Opportunistic Salpingectomy to Prevent Ovarian Cancer

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Multi-Disciplinary Approach to the Opportunistic Salpingectomy for Primary Prevention of Ovarian Cancer

Quick Facts

Study Start:2024-03-08

Study Completion:2028-03-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06312124

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age ≥45 years * Scheduled visit with a nongynecologic surgeon * Female or assigned female at birth * 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 * 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	* Not fluent in English * Known inherited ovarian cancer susceptibility * 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

Inclusion Criteria

Exclusion Criteria

* Age ≥45 years
* Scheduled visit with a nongynecologic surgeon
* Female or assigned female at birth
* 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
* 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

* Not fluent in English
* Known inherited ovarian cancer susceptibility
* 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

Contacts and Locations

Study Contact

Kara Long Roche, MD

CONTACT

212-639-7043

longrock@mskcc.org

Martin Weiser, MD

CONTACT

212-639-6698

weiser1@mskcc.org

Principal Investigator

Kara Long Roche, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Johns Hopkins University (Data Collection Only)

Baltimore, Maryland, 21287

United States

Dana Farber Cancer Institute (Data Collection Only)

Boston, Massachusetts, 02115

United States

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920

United States

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645

United States

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

Commack, New York, 11725

United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604

United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065

United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553

United States

MD Anderson Cancer Center (Data Collection Only)

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Kara Long Roche, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-08

Study Completion Date2028-03-08

Study Record Updates

Study Start Date2024-03-08

Study Completion Date2028-03-08

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Surgery