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

Stopped early

Conditions studied: Adnexal Mass

In brief

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.

Key facts

Study ID

NCT04487405

Run by

Aspira Women's Health

People needed

721

Starts

2020-06-25

Expected to finish

2023-12-15

Last updated by the study team

2023-12-26

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patient is less than 18 years of age
• Patient is not being treated in the U.S.

Where it is running

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

Full record on ClinicalTrials.gov

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