Multifactorial Risk Assessment for Breast & Ovarian Cancer Risk Detection

  • End date
    Dec 30, 2024
  • participants needed
  • sponsor
    Aspira Women's Health
Updated on 4 October 2022


The objective of this project is to validate a next-generation assay that utilizes both the protein biomarkers of our already established ovarian cancer risk assessment combined with a molecular profile in both germline and early somatic detection.

Condition Hereditary Breast and Ovarian Cancer, Adnexal Mass, Hereditary Breast and Ovarian Cancer Syndrome, Germline BRCA1 Gene Mutation, Germline BRCA2 Gene Mutation
Treatment OVA360
Clinical Study IdentifierNCT04668521
SponsorAspira Women's Health
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

Female subject
years of age or older
Cohort A specific inclusion criteria
Diagnosed with a pelvic mass
Cohort B specific inclusion criteria
Diagnosed with a pelvic mass
Undergoing genetic testing through our commercial offering
Cohort C specific inclusion criteria
Subject must not have an identifiable adnexal mass and may, or may not, have a
family history or a known familial genetic abnormality (germ line or
identified in family cancer i.e. somatic DNA mutation) associated with ovarian

Exclusion Criteria

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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