A Multivariate Index Assay for Ovarian Cancer Risk Assessment in Women With Adnexal Mass and High-Risk Germline Variants
NCT ID: NCT04487405
Last Updated: 2023-12-26
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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TERMINATED
721 participants
OBSERVATIONAL
2020-06-25
2023-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Group A
Symptomatic with adnexal mass
OVAnex
OVAnex is a multivarite index assay assessing ovarian cancer risk
Group B
Asymptomatic with adnexal mass
OVAnex
OVAnex is a multivarite index assay assessing ovarian cancer risk
Group C
Women with a predisposition in developing ovarian cancer due to a positive, pathogenic variant
OVAnex
OVAnex is a multivarite index assay assessing ovarian cancer risk
Interventions
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OVAnex
OVAnex is a multivarite index assay assessing ovarian cancer risk
Eligibility Criteria
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Inclusion Criteria
* Patient reviewed, understood, and provided the PI with written informed consent to allow blood specimen to be used for research and release of medical information.
Exclusion Criteria
* Patient is not being treated in the U.S.
18 Years
FEMALE
No
Sponsors
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Aspira Women's Health
INDUSTRY
Responsible Party
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Principal Investigators
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Todd Pappas, PhD
Role: PRINCIPAL_INVESTIGATOR
Aspira Women's Health
Locations
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Women's Health Arizona
Chandler, Arizona, United States
Altus Research
Lake Worth, Florida, United States
MidTown OBGYN
Columbus, Georgia, United States
Premier OBGYN of Minnesota
Eden Prairie, Minnesota, United States
Square Care Health
New Hyde Park, New York, United States
Northwell Health
New Hyde Park, New York, United States
Seven Hills Clinical Research Group
Cincinnati, Ohio, United States
May Grant OB/GYN
Lancaster, Pennsylvania, United States
Hill Country OBGYN Associates
Austin, Texas, United States
Countries
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Other Identifiers
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04-2019
Identifier Type: -
Identifier Source: org_study_id