Universal Genetic Testing for Cancer Risk Reduction

NYU Langone Health

Status: Enrolling

Conditions: Genetic Testing

Treatments: Other: Specialist Referral; Genetic: Natera® Empower™ hereditary cancer panel test

Study type: Interventional

Funder types: Other

Identifiers

NCT06926816

23-00413

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: Female

Ages: 25 to 39 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

Completed genetic screening test

Experimental group

Description:

Participants will complete point-of-care genetic testing by saliva test. Participants with actionable pathogenic variants will be referred to the appropriate specialists to discuss risk-reduction strategies and offered genetic counseling. All Participants will be given the opportunity for genetic counseling, and if interested and desired this will be facilitated by the research team.

Treatment:

Other: Specialist Referral

Genetic: Natera® Empower™ hereditary cancer panel test

Denied genetic screening test

No Intervention group

Description:

Participants in this arm have declined the genetic screening test.