Universal Genetic Testing for Cancer Risk Reduction
Part of paid clinical trials in New York, New York.
- Sponsor
- NYU Langone Health
- Study ID
- NCT06926816
- Status
- Recruiting
Conditions
- Genetic Testing
Eligibility Criteria
- Sex
- FEMALE
- Age
- 25 Years - 39 Years
- Healthy Volunteers
- Accepted
Interventions
- Natera® Empower™ hereditary cancer panel test — GENETICThe test will be the Natera® Empower™ hereditary cancer panel test and will be collected by saliva.
- Specialist Referral — OTHERParticipants with actionable pathogenic variants will be referred to the appropriate specialists (e.g., medical oncologist, gynecologic oncologist, breast surgeon) to discuss risk-reduction strategies and offered genetic counseling
Study Details
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.
Key Dates
- Start date
- Mar 4, 2025
- Status verified
- Feb 2026
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 600 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SCREENING
Arms
- Experimental: Completed genetic screening testParticipants will complete point-of-care genetic testing by saliva test. Participants with actionable pathogenic variants will be referred to the appropriate specialists to discuss risk-reduction strategies and offered genetic counseling. All Participants will be given the opportunity for genetic counseling, and if interested and desired this will be facilitated by the research team.
- No Intervention: Denied genetic screening testParticipants in this arm have declined the genetic screening test.
Primary Outcome Measure
Number of participants who undergo genetic testing [ Time Frame: Up to 9 months ]
Central Contacts
- Bhavana Pothuri, MD, MS212-731-6455
- Sarah Lee646-501-7876
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | - |
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