Validation Study of Liquid Biopsy Accuracy Compared to Mammography in Breast Cancer Detection

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 groups 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.

A Validation Study to Determine Concordance of Liquid Biopsy and Breast Cancer Diagnosis