Status:
TERMINATED
A Multivariate Index Assay for Ovarian Cancer Risk Assessment in Women With Adnexal Mass and High-Risk Germline Variants
Lead Sponsor:
Aspira Women's Health
Conditions:
Adnexal Mass
Eligibility:
FEMALE
18+ years
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Patient is less than 18 years of age
- Patient is not being treated in the U.S.
Key Trial Info
Start Date :
June 25 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 15 2023
Estimated Enrollment :
721 Patients enrolled
Trial Details
Trial ID
NCT04487405
Start Date
June 25 2020
End Date
December 15 2023
Last Update
December 26 2023
Active Locations (9)
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1
Women's Health Arizona
Chandler, Arizona, United States, 85224
2
Altus Research
Lake Worth, Florida, United States, 33461
3
MidTown OBGYN
Columbus, Georgia, United States, 31901
4
Premier OBGYN of Minnesota
Eden Prairie, Minnesota, United States, 55344