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

Aspira Women's Health

Status: Terminated

Conditions: Adnexal Mass

Treatments: Device: OVAnex

Study type: Observational

Funder types: Industry

Identifiers

NCT04487405

04-2019

Details and patient eligibility

About

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.

Enrollment: 721 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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.

Trial design

721 participants in 3 patient groups

Group A

Description:

Symptomatic with adnexal mass

Treatment:

Device: OVAnex

Group B

Description:

Asymptomatic with adnexal mass

Treatment:

Device: OVAnex

Group C

Description:

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

Treatment:

Device: OVAnex