Status:
TERMINATED
Multifactorial Risk Assessment for Breast & Ovarian Cancer Risk Detection
Lead Sponsor:
Aspira Women's Health
Conditions:
Adnexal Mass
Germline BRCA1 Gene Mutation
Eligibility:
FEMALE
18+ years
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 profi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 4 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 15 2023
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT04668521
Start Date
May 4 2020
End Date
December 15 2023
Last Update
December 26 2023
Active Locations (1)
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1
Silvana Franco
Austin, Texas, United States, 78738