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Recruiting

NCT Number: NCT06926816

Universal Genetic Testing for Cancer Risk Reduction

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.

Recruiting

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Key information

Conditions

Genetic Testing Neoplasms

Age range

25 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

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 outcomes

  1. Number of participants who undergo genetic testing

    Time frame: Up to 9 months

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

Secondary outcomes

  1. Number of participants with pathogenic variants

    Time frame: Up to 9 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Bhavana Pothuri, MD, MS

CONTACT

[email protected]

212-731-6455

Sarah Lee

CONTACT

[email protected]

646-501-7876

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 15, 2025
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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