Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
600 participants
INTERVENTIONAL
2025-03-04
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Completed genetic screening test
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.
Natera® Empower™ hereditary cancer panel test
The test will be the Natera® Empower™ hereditary cancer panel test and will be collected by saliva.
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
Denied genetic screening test
Participants in this arm have declined the genetic screening test.
No interventions assigned to this group
Interventions
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Natera® Empower™ hereditary cancer panel test
The test will be the Natera® Empower™ hereditary cancer panel test and will be collected by saliva.
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
Eligibility Criteria
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Inclusion Criteria
2. Receive gynecologic care at an affiliated NYU Langone Health (NYULH) site listed in this protocol.
Exclusion Criteria
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)
25 Years
39 Years
FEMALE
Yes
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Bhavana Pothuri, MD, MS
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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NYU Langone Health
New York, New York, United States
Countries
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Central Contacts
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Other Identifiers
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23-00413
Identifier Type: -
Identifier Source: org_study_id
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