Genetic testing for cancer risk in women visiting gynecology clinics
Universal Genetic Testing for Cancer Risk Reduction
NA · NYU Langone Health · NCT06926816
This study is testing if offering genetic testing for cancer risk during gynecology visits is helpful and accepted by women aged 25-39.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 25 Years to 39 Years |
| Sex | Female |
| Sponsor | NYU Langone Health (other) |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06926816 on ClinicalTrials.gov |
What this trial studies
This research aims to evaluate the feasibility and acceptability of offering genetic testing for cancer-related genes to female patients aged 25-39 during their gynecology clinic visits. The study will assess how many patients choose to undergo genetic testing and the proportion of those who have pathogenic variants. By integrating genetic testing into routine gynecological care, the study seeks to simplify access to important cancer risk information without requiring specialized referrals. The intervention involves the Natera® Empower™ hereditary cancer panel test.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 25-39 receiving gynecologic care at NYU Langone Health.
Not a fit: Patients with a personal history of specific cancers or those who have already undergone germline testing for ovarian cancer risk may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier identification of cancer risks in women, enabling proactive management and prevention strategies.
How similar studies have performed: While the approach of integrating genetic testing into routine care is gaining traction, this specific study's methodology is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
New York, New York
- NYU Langone Health — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Bhavana Pothuri, MD, MS — NYU Langone Health
- Study coordinator: Bhavana Pothuri, MD, MS
- Email: Bhanava.pothuri@nyulangone.org
- Phone: 212-731-6455
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Genetic Testing, Cancer