TerminatedNot Applicable

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

Stopped: cohort C looked at feasibility of genetics \& protein to evaluate risk with a family hx of cancer or associated variant. Since few patients show these factors, this approach would not yield sufficient information to make inferences

United States721 participantsStarted 2020-06-25

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

OVAnex

Timeframe: 12 months

Trial details

NCT IDNCT04487405

SponsorAspira Women's Health

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-12-15

View on ClinicalTrials.gov More Adnexal Mass trials