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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04487405

Acronym

OVAnex

Enrollment

721

Registered

2020-07-27

Start date

2020-06-25

Completion date

2023-12-15

Last updated

2023-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adnexal Mass

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.

Interventions

DEVICEOVAnex

OVAnex is a multivarite index assay assessing ovarian cancer risk

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026