Universal Genetic Testing for Cancer Risk Reduction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Natera® Empower™ hereditary cancer panel test, Specialist Referral.
- Who it may be relevant to
- Registry conditions: Genetic Testing. Basic parameters: 25 years — 39 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Genetic Natera® Empower™ hereditary cancer panel test
The test will be the Natera® Empower™ hereditary cancer panel test and will be collected by saliva. - Other Specialist 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
Primary outcome measures
- Number of participants who undergo genetic testing [Time frame: Up to 9 months]
Secondary outcome measures (1)
- Number of participants with pathogenic variants [Time frame: Up to 9 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Screening
Study locations
United States · 1 center
- NYU Langone Health — New York
Identifiers
NCT: NCT06926816 · 23-00413