A Validation Study to Determine Concordance of Liquid Biopsy and Breast Cancer Diagnosis
University of Southern California
Summary
This study evaluates whether a special type of blood analysis, called liquid biopsy (LBx), correlates with mammography results and/or diagnosis of breast cancer.
Description
PRIMARY OBJECTIVES: I. Determine the sensitivity of LBx for the presence of breast cancer in patient cohorts II. Determine the specificity of LBx for the presence of breast cancer in all patient cohorts. OUTLINE: This is an observational study. Patients undergo blood sample collection and have their medical records reviewed on study.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * \* Women * Age ≥ 18 years. * Screening Mammography Cohort: Patients who were referred for screening mammography and had mammography performed within 6 months prior to blood draw or will be undergoing mammography within 6 months after blood draw. Patient must not have personal history of breast cancer, history of breast biopsy or prior abnormal mammography findings are allowed. OR * Abnormal Screening Cohort: Patient who has had mammography that revealed abnormal results (BIRADS 3, 4, 5) or abnormal MRI results requiring further testing (additional imaging modality…
Interventions
- OtherNon-Interventional Study
Non-interventional study
Locations (4)
- Keck Medicine of USC KoreatownLos Angeles, California
- Los Angeles General Medical CenterLos Angeles, California
- USC / Norris Comprehensive Cancer CenterLos Angeles, California
- USC Norris Oncology/Hematology-Newport BeachNewport Beach, California