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

Sponsor

Aspira Women's Health (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04487405

Collaborator

(none)

4,661

Enrollment

Location

126.2

Anticipated Duration (Months)

36.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adnexal Mass	Device: OVAnex

Study Design

Study Type:

Observational

Anticipated Enrollment :

4661 participants

Observational Model:

Case-Control

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

Jun 25, 2020

Anticipated Primary Completion Date :

Dec 30, 2030

Anticipated Study Completion Date :

Dec 30, 2030

Arms and Interventions

Arm	Intervention/Treatment
Group A Symptomatic with adnexal mass	Device: OVAnex OVAnex is a multivarite index assay assessing ovarian cancer risk
Group B Asymptomatic with adnexal mass	Device: OVAnex OVAnex is a multivarite index assay assessing ovarian cancer risk
Group C Women with a predisposition in developing ovarian cancer due to a positive, pathogenic variant	Device: OVAnex OVAnex is a multivarite index assay assessing ovarian cancer risk

Arm

Intervention/Treatment

Group A

Symptomatic with adnexal mass

Device: OVAnex

OVAnex is a multivarite index assay assessing ovarian cancer risk

Group B

Asymptomatic with adnexal mass

Device: OVAnex

OVAnex is a multivarite index assay assessing ovarian cancer risk

Group C

Women with a predisposition in developing ovarian cancer due to a positive, pathogenic variant

Device: OVAnex

OVAnex is a multivarite index assay assessing ovarian cancer risk

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seven Hills Clinical Research Group	Cincinnati	Ohio	United States	45211

Sponsors and Collaborators

Aspira Women's Health

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aspira Women's Health

ClinicalTrials.gov Identifier:

NCT04487405

Other Study ID Numbers:

04-2019

First Posted:

Jul 27, 2020

Last Update Posted:

Aug 24, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 24, 2021