A Multivariate Index Assay for Ovarian Cancer Risk Assessment in Women With Adnexal Mass and High-Risk Germline Variants
- Conditions
- Adnexal Mass
- Registration Number
- NCT04487405
- Lead Sponsor
- Aspira Women's Health
- Brief Summary
The objective of this project is to validate the sensitivity, specificity, positive predictive value and negative predictive values of the AMRA blood test for assessing risk of cancer in women at high risk for ovarian cancer, due to the presence of a symptomatic adnexal mass.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 721
- Female patient, 18 years of age or older diagnosed with an ovarian adnexal mass, or in follow-up due to the presence of BRCA1/2 and other germline DNA variants.
- 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.
- Patient is less than 18 years of age
- Patient is not being treated in the U.S.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method OVAnex 12 months OVAnex is a multivariate index assay assessing ovarian cancer risk. The Ovanex MIA uses seven biomarkers with a stepwise algorithm to generate a risk score which ranges from 0 to 20.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
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
Women's Health Arizona🇺🇸Chandler, Arizona, United States