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 — GENETIC
    The test will be the Natera® Empower™ hereditary cancer panel test and will be collected by saliva.
  • Specialist Referral — OTHER
    Participants 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 test
    Participants 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 test
    Participants 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

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

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