RecruitingInterventional

Universal Genetic Testing for Cancer Risk Reduction

NCT ID: NCT06926816Sponsor: NYU Langone HealthLast updated: 2026-03-02

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.

Arms & 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

Outcome measures

Primary

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

Secondary

Number of participants with pathogenic variants
Time frame: Up to 9 months

Eligibility criteria

Sex: FemaleAge: 25 Years to 39 YearsHealthy 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)

Study locations (1)

NYU Langone Health

New York, New York, 10016

Recruiting