Recruiting

Genetic Testing

Sponsor:

NYU Langone Health

Code:

NCT06926816

Conditions

Genetic Testing

Eligibility Criteria

Sex: Female

Age: 25 - 39

Healthy Volunteers: Accepted

Interventions

Natera® Empower™ hereditary cancer panel test

Specialist Referral

Study Details

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.

Conditions

Genetic Testing

Study ID

NCT06926816

Start date

Mar 4, 2025

Status verified date

Feb, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 25 - 39

Healthy Volunteers: Accepted

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

Enrollment

600 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

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.

Interventions

Natera® Empower™ hereditary cancer panel test

The test will be the Natera® Empower™ hereditary cancer panel test and will be collected by saliva.

Specialist Referral

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

Primary outcome measure

  • Number of participants who undergo genetic testing [ Time Frame: Up to 9 months ]

Central Contacts and Locations

Central contacts

Bhavana Pothuri, MD, MS

212-731-6455Bhanava.pothuri@nyulangone.org

Sarah Lee

646-501-7876Sarah.lee@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Mar 2, 2026

Last verified

Feb, 2026

Keywords

  • Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-03-02.