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NCT04487405: OVAnex

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

Terminated Last updated 26 December 2023
What this trial tests

trial testing OVAnex in Adnexal Mass in 721 participants. Terminated before completion.

Timeline
25 June 2020
Primary endpoint
15 December 2023
15 December 2023

Quick facts

Lead sponsorAspira Women's Health
StatusTerminated
Study typeOBSERVATIONAL
Enrollment721
Start date25 June 2020
Primary completion15 December 2023
Estimated completion15 December 2023
Sites9 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Aspira Women's Health

Who can join

18 and older, female only, with Adnexal Mass. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Diagnostic biomarkers in ovarian cancer: advances beyond CA125 and HE4.
    Ghose A, McCann L, Makker S, Mukherjee U, et al · · 2024 · cited 75× · PMID 38435431 · DOI 10.1177/17588359241233225

Verify or expand the search:

Other recruiting trials for Adnexal Mass

Currently open trials in the same condition.

Other Aspira Women's Health trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04487405.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing