Actively Recruiting
Universal Genetic Testing for Cancer Risk Reduction in Women Ages 25 to 39 During Gynecology Visits
Led by NYU Langone Health · Updated on 2026-03-02
600
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research study is focused on evaluating the feasibility and acceptance of offering genetic testing for cancer-related genes to female patients during gynecology clinic visits. The aim is to determine how many patients undergo genetic testing and how many have disease-related genetic variants without needing to see specialized providers or meet strict criteria. The study is sponsored by NYU Langone Health and targets women aged 25 to 39 years. Participants will be offered the Natera® Empower™ hereditary cancer panel test, which is a saliva-based genetic test. Those who test positive for actionable pathogenic variants will be referred to specialists such as medical oncologists, gynecologic oncologists, or breast surgeons for discussions about risk-reduction options. All participants can access genetic counseling, which the research team can arrange if desired. There are two groups: those who complete the genetic screening and those who decline it. During the study, participants will provide saliva samples for genetic testing at the point of care. Researchers will track the number of participants who complete testing and identify those with pathogenic variants over a period of up to nine months. Participants may receive referrals and counseling based on their results. The study allows healthy volunteers and runs through the end of 2027, with no masking or randomization involved.
CONDITIONS
Brief Title
Universal Genetic Testing for Cancer Risk Reduction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients between ages of 25-39 years at the time of visit
- Receive gynecologic care at an affiliated NYU Langone Health site listed in this protocol
You will not qualify if you...
- Personal history of ovarian, fallopian tube, primary peritoneal, or uterine cancers
- Previously undergone germline testing for ovarian cancer risk variants (prior commercial saliva-based kits, such as 23andMe, are acceptable)
- History of bilateral salpingo-oophorectomy
- Visit related to pregnancy or immediately postpartum (within 2 weeks)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) during gynecology visit
Duration - Up to 9 months
Participants undergo genetic testing with a saliva sample and may be referred to specialists for risk-reduction strategies and genetic counseling if actionable variants are found. Participants who decline testing are observed without intervention.
1 visit for saliva test collection; additional visits for specialist referral and counseling as needed
Trial Site Locations
Total: 1 location
1
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
Research Team
B
Bhavana Pothuri, MD, MS
S
Sarah Lee
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
2
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