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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2030
  • participants needed
    4661
  • sponsor
    Aspira Women's Health
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Updated on 5 August 2020
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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.

Details
Condition Adnexal Mass
Age 18years - 100years
Treatment OVAnex
Clinical Study IdentifierNCT04487405
SponsorAspira Women's Health
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

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
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