What this study is
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.
What's being tested
- Natera® Empower™ hereditary cancer panel test
Intervention · GENETIC
The test will be the Natera® Empower™ hereditary cancer panel test and will be collected by saliva.
- Specialist Referral
Intervention · 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
- Sponsor
- NYU Langone Health
- Conditions
- Genetic Testing
- Enrolling
- 600 people
- Starts
- 2025-03-04
- Est. completion
- 2027-12-31
- Design
- Open-label, non-randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 25 Years – 39 YearsSex FEMALEHealthy volunteers AcceptedYou may qualify if
- Female patients between ages of 25-39 years at the time of visit
- Receive gynecologic care at an affiliated NYU Langone Health (NYULH) site listed in this protocol.
You can't join if
- 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)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openNYU Langone Health
New York, New York, United States
Recruiting
Study team
Sponsor
NYU Langone Health
Study ID 23-00413
Principal investigator
Bhavana Pothuri, MD, MS
NYU Langone Health
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.