Actively Recruiting
A Validation Study to Determine Concordance of Liquid Biopsy and Breast Cancer Diagnosis
Led by University of Southern California · Updated on 2026-03-12
490
Participants Needed
4
Research Sites
313 weeks
Total Duration
On this page
Sponsors
U
University of Southern California
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study evaluates whether a special type of blood analysis, called liquid biopsy (LBx), correlates with mammography results and/or diagnosis of breast cancer.
CONDITIONS
Official Title
A Validation Study to Determine Concordance of Liquid Biopsy and Breast Cancer Diagnosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 years or older
- Screening Mammography Cohort: Patients referred for screening mammography with mammogram within 6 months before or after blood draw; no personal history of breast cancer but history of breast biopsy or prior abnormal mammography allowed
- Abnormal Screening Cohort: Patients with abnormal mammography (BIRADS 3, 4, 5) or abnormal MRI needing further testing; no history of breast cancer; blood draw between abnormal imaging and start of definitive treatment; no prior surgery or excisional biopsy for abnormal findings
- New Breast Cancer Cohort: Patients with new biopsy-proven breast cancer diagnosis within 60 days of blood draw; no prior cancer-directed therapy started
- Remission Breast Cancer Cohort: Patients with treated localized breast cancer (stage 1-3) in remission; completed surgery, chemotherapy, and/or radiation before enrollment; blood draw at least 90 days after treatment; patients on adjuvant hormonal therapy eligible if CDK4/6 inhibitor therapy completed
You will not qualify if you...
- Unable to give informed consent
- Received blood transfusion within 14 days before study blood draw
- Had heart attack, stroke, or pulmonary embolism within 3 months before study blood draw
- Had excisional breast biopsy within 30 days before study blood draw; needle biopsy is allowed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Keck Medicine of USC Koreatown
Los Angeles, California, United States, 90020
Actively Recruiting
2
Los Angeles General Medical Center
Los Angeles, California, United States, 90033
Actively Recruiting
3
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
4
USC Norris Oncology/Hematology-Newport Beach
Newport Beach, California, United States, 92663
Actively Recruiting
Research Team
K
Kimberly Arieli, RN
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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