Universal Genetic Testing for Cancer Risk Reduction

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06926816

Enrollment

600

Registered

2025-04-15

Start date

2025-03-04

Completion date

2027-12-31

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genetic Testing

Keywords

Cancer

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.

Interventions

GENETICNatera® Empower™ hereditary cancer panel test

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

OTHERSpecialist 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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

25 Years to 39 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

United States

Contacts

CONTACTBhavana Pothuri, MD, MS

Bhanava.pothuri@nyulangone.org212-731-6455

CONTACTSarah Lee

Sarah.lee@nyulangone.org646-501-7876

PRINCIPAL_INVESTIGATORBhavana Pothuri, MD, MS

NYU Langone Health

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026