A Multivariate Index Assay for Ovarian Cancer Risk Assessment in Women With Adnexal Mass and High-Risk Germline Variants

Aspira Women's Health9 sites in 1 country721 target enrollmentJune 25, 2020

ConditionsAdnexal Mass

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Adnexal Mass
Sponsor: Aspira Women's Health
Enrollment: 721
Locations: 9
Primary Endpoint: OVAnex
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 25, 2020

End Date

December 15, 2023

Last Updated

2 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Aspira Women's Health

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•Patient is less than 18 years of age
•Patient is not being treated in the U.S.

Outcomes

Primary Outcomes

OVAnex

Time Frame: 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.