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