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

December 19, 2023 updated by: Aspira Women's Health
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

721

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Women's Health Arizona
    • Florida
      • Lake Worth, Florida, United States, 33461
        • Altus Research
    • Georgia
      • Columbus, Georgia, United States, 31901
        • MidTown OBGYN
    • Minnesota
      • Eden Prairie, Minnesota, United States, 55344
        • Premier OBGYN of Minnesota
    • New York
      • New Hyde Park, New York, United States, 11042
        • Northwell Health
      • New Hyde Park, New York, United States, 11040
        • Square Care Health
    • Ohio
      • Cincinnati, Ohio, United States, 45211
        • Seven Hills Clinical Research Group
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17601
        • May Grant OB/GYN
    • Texas
      • Austin, Texas, United States, 78748
        • Hill Country OBGYN Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult women with an ovarian adnexal mass, or in follow up due to the presence of BRCA1/2 and other germline DNA variants.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aspira Women's Health

Investigators

  • Principal Investigator: Todd Pappas, PhD, Aspira Women's Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2020

Primary Completion (Actual)

December 15, 2023

Study Completion (Actual)

December 15, 2023

Study Registration Dates

First Submitted

July 10, 2020

First Submitted That Met QC Criteria

July 22, 2020

First Posted (Actual)

July 27, 2020

Study Record Updates

Last Update Posted (Actual)

December 26, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 04-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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