Adnexal Mass, Germline BRCA1 Gene Mutation, Germline BRCA2 Gene Mutation, Hereditary Breast and Ovarian Cancer
Conditions
Brief summary
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.
Interventions
OTHEROVA360
Multifactorial Risk Assessment for Breast & Ovarian Cancer Risk Detection
Sponsors
Aspira Women's Health
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Key inclusion criteria: * Female subject * 18 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 cancer.
Exclusion criteria
* n/a
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OVA360 | 12 months | Identify the molecular key driver of Ovarian cancer and develop a diagnostic test for early Ovarian cancer detection |
Countries
United States
Outcome results
None listed