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Multimodal Liquid-Biopsy Omics Biomarkers of Treatment Response in Breast Cancer
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Summary
This single-center cohort study integrates humoral immune response profiling (Phage ImmunoPrecipitation Sequencing, PhIP-seq) with circulating cell-free DNA (cfDNA) genomic and epigenomic features, exosome transcriptomics, and plasma metabolomics to discover and validate liquid-biopsy biomarkers of treatment response in breast cancer. The study comprises four cohorts: (1) a retrospective pan-cancer cohort of approximately 1,000 patients with solid malignant tumor, using archived residual serum/plasma to construct a pan-cancer antigen repertoire and cfDNA mutational/methylation atlas, with priority given to patients who had available Whole Exome Sequencing (WES) data; (2) a prospective cohort of 800 women with non-metastatic (M0) breast cancer receiving standard neoadjuvant chemotherapy (NAC); (3) a prospective cohort of 100 women with metastatic (M1) breast cancer receiving standard systemic therapy; and (4) a control group of 100 individuals, including patients with benign breast disease (breast fibroadenoma) and healthy volunteers. The primary objective is to identify biomarkers-autoantibody repertoires, cfDNA mutation clearance, methylation reprogramming, exosome transcripts, and metabolic signatures-associated with pathological complete response (pCR) to NAC, and to develop predictive models where feasible.
Official title: Exploration of Treatment-Response Biomarkers in Breast Cancer Based on Integrated Liquid-Biopsy Multimodal Omics Features
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
OBSERVATIONAL
Enrollment
2000
Start Date
2026-10-01
Completion Date
2034-12-30
Last Updated
2026-10-19
Healthy Volunteers
Yes
Conditions
Locations (1)
Shenshan Medical Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Shanwei, Guangdong, China