Universal Genetic Testing for Cancer Risk Reduction

Not Applicable

Recruiting

• Conditions: Genetic Testing

• Registration Number: NCT06926816
• Lead Sponsor: NYU Langone Health

Brief Summary

The purpose of this research study is to see if offering genetic testing for cancer-related genes is feasible and acceptable for patients presenting for gynecology clinic visits, instead of needing to see specialized providers or needing to meet specific criteria. The primary aim to assess the proportion of patients who undergo genetic testing, and the proportion of patients with pathogenic variants.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-04
• Status Verified: 2025-04
• Study First Submitted: 2025-04-11
• Study First Submitted QC: 2025-04-11
• Last Update Submitted: 2025-04-11
• Study First Posted: 2025-04-15
• Last Update Posted: 2025-04-15
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

1. Female patients between ages of 25-39 years at the time of visit
2. Receive gynecologic care at an affiliated NYU Langone Health (NYULH) site listed in this protocol.

Exclusion Criteria

1. Personal history of ovarian, fallopian tube, primary peritoneal, or uterine cancers
2. Previously undergone germline testing for ovarian cancer risk variants (prior commercial saliva-based kits, such as 23andMe, are acceptable)
3. History of bilateral salpingo-oophorectomy
4. Visit related to pregnancy or immediately postpartum (within 2 weeks)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of participants who undergo genetic testing	Up to 9 months	Outcome measure will be assessed via review of electronic medical record (EMR).

Secondary Outcome Measures

Name	Time	Method
Number of participants with pathogenic variants	Up to 9 months	Outcome measure will be assessed via review of Natera® Empower™ hereditary cancer panel test results.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States