Ovarian Cancer Clinical Trial

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

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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.

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Eligibility Criteria

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.

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

721

Study ID:

NCT04487405

Recruitment Status:

Terminated

Sponsor:

Aspira Women's Health

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There are 9 Locations for this study

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Women's Health Arizona
Chandler Arizona, 85224, United States
Altus Research
Lake Worth Florida, 33461, United States
MidTown OBGYN
Columbus Georgia, 31901, United States
Premier OBGYN of Minnesota
Eden Prairie Minnesota, 55344, United States
Square Care Health
New Hyde Park New York, 11040, United States
Northwell Health
New Hyde Park New York, 11042, United States
Seven Hills Clinical Research Group
Cincinnati Ohio, 45211, United States
May Grant OB/GYN
Lancaster Pennsylvania, 17601, United States
Hill Country OBGYN Associates
Austin Texas, 78748, United States
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How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

721

Study ID:

NCT04487405

Recruitment Status:

Terminated

Sponsor:


Aspira Women's Health

How clear is this clinincal trial information?

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