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

Adnexal Mass Clinical Trial

— OVAnex  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04487405
• Other study ID #: 04-2019
• Status: Terminated
• Start date: June 25, 2020
• Est. completion date: December 15, 2023

Study information

• Verified date: December 2023
• Source: Aspira Women's Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 721
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adnexal Mass

Intervention

Device:
• OVAnex
OVAnex is a multivarite index assay assessing ovarian cancer risk

Locations

Country	Name	City	State
United States	Hill Country OBGYN Associates	Austin	Texas
United States	Women's Health Arizona	Chandler	Arizona
United States	Seven Hills Clinical Research Group	Cincinnati	Ohio
United States	MidTown OBGYN	Columbus	Georgia
United States	Premier OBGYN of Minnesota	Eden Prairie	Minnesota
United States	Altus Research	Lake Worth	Florida
United States	May Grant OB/GYN	Lancaster	Pennsylvania
United States	Northwell Health	New Hyde Park	New York
United States	Square Care Health	New Hyde Park	New York

Sponsors (1)

Lead Sponsor	Collaborator
Aspira Women's Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OVAnex	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.	12 months