Universal Genetic Testing for Cancer Risk Reduction

ConditionGenetic Testing

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age25-39

SponsorNYU Langone Health

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

Natera® Empower™ hereditary cancer panel test
Genetic
The test will be the Natera® Empower™ hereditary cancer panel test and will be collected by saliva.
Specialist Referral
Other intervention
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

Treatment groups

600 Participants

are divided into 2 treatment groups

Group A: Completed genetic screening testExperimental treatment 2 interventions

Group B: Denied genetic screening testNo intervention 0 interventions

Trial outcomes

Primary outcomes

Number of participants who undergo genetic testing

Outcome measure will be assessed via review of electronic medical record (EMR).

Time frame

Up to 9 months

Secondary outcomes

Number of participants with pathogenic variants

Outcome measure will be assessed via review of Natera® Empower™ hereditary cancer panel test results.

Time frame

Up to 9 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NYU Langone Health

Lead sponsor

Source ClinicalTrials.gov

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