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

Terminated

• Conditions: Adnexal Mass
• Interventions: Device: OVAnex

• 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

Study Timeline

• Study Start: 2020-06-25
• Study First Submitted: 2020-07-10
• Study First Submitted QC: 2020-07-22
• Study First Posted: 2020-07-27
• Status Verified: 2023-12
• Primary Completion: 2023-12-15
• Study Completion: 2023-12-15
• Last Update Submitted: 2023-12-19
• Last Update Posted: 2023-12-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 721

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A	OVAnex	Symptomatic with adnexal mass
Group B	OVAnex	Asymptomatic with adnexal mass
Group C	OVAnex	Women with a predisposition in developing ovarian cancer due to a positive, pathogenic variant

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.

Trial Locations

Locations (9)

Northwell Health; 🇺🇸 New Hyde Park, New York, United States

Altus Research; 🇺🇸 Lake Worth, Florida, United States

Women's Health Arizona; 🇺🇸 Chandler, Arizona, United States

May Grant OB/GYN; 🇺🇸 Lancaster, Pennsylvania, United States

Hill Country OBGYN Associates; 🇺🇸 Austin, Texas, United States

Square Care Health; 🇺🇸 New Hyde Park, New York, United States

MidTown OBGYN; 🇺🇸 Columbus, Georgia, United States

Premier OBGYN of Minnesota; 🇺🇸 Eden Prairie, Minnesota, United States

Seven Hills Clinical Research Group; 🇺🇸 Cincinnati, Ohio, United States