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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
52 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
Researchers are evaluating a special blood test called liquid biopsy (LBx) to see how well it matches mammography results and breast cancer diagnosis. The study aims to determine how sensitive and specific LBx is in detecting breast cancer across different patient groups. This observational study is sponsored by the University of Southern California and focuses on women aged 18 and older, including those undergoing screening, with abnormal imaging, new breast cancer diagnosis, or in remission from breast cancer. Participants provide a blood sample and have their medical records reviewed. The study includes several groups: women referred for screening mammography, patients with abnormal mammography or MRI results needing further testing, newly diagnosed breast cancer patients who have not yet started treatment, and patients in remission after completing therapy. Blood draws are timed according to each group's specific criteria, such as within six months of mammography or within 60 days of diagnosis. During the study, researchers collect blood samples and review medical records to compare LBx results with mammography and cancer diagnosis. They measure the sensitivity and specificity of LBx as a screening method for breast cancer over up to one year. Participants' involvement includes providing blood samples and allowing access to their medical history. The study monitors outcomes without administering any interventions, and participation lasts as long as needed to assess these diagnostic measures.
CONDITIONS
Brief 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
- Patients referred for screening mammography with mammography performed within 6 months before or after blood draw; no personal history of breast cancer; history of breast biopsy or abnormal mammography allowed
- Patients with abnormal mammography (BIRADS 3, 4, 5) or abnormal MRI needing further testing; no history of breast cancer; blood draw between abnormal mammography and treatment start; no prior surgery or excisional biopsy for these findings
- Patients with new biopsy-proven breast cancer diagnosis within 60 days of blood draw who have not started any cancer treatment; any breast cancer type and stage
- Patients in remission from localized breast cancer (stage 1, 2, 3) after completing surgery, chemotherapy, radiation; 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...
- Patients unable to give informed consent
- Patients who received blood transfusion within 14 days before blood draw
- Patients who had heart attack, stroke, or pulmonary embolism within 3 months before blood draw
- Patients with excisional breast biopsy within 30 days before blood draw; needle biopsy allowed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 1 year
Participants provide blood samples for analysis and have their medical records reviewed as part of the study.
1 to 2 visits depending on cohort assignment
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
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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