NCT07880106Not yet recruiting
Multimodal Liquid-Biopsy Omics Biomarkers of Treatment Response in Breast Cancer
Exploration of Treatment-Response Biomarkers in Breast Cancer Based on Integrated Liquid-Biopsy Multimodal Omics Features
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 2000 (estimated)
- First submitted
- 11 Oct 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 30 Jun 2030
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Diseases
- Lung cancer, Colorectal cancer, Liver and biliary tract cancer, Gastric and esophageal cancer
- NCT number
- NCT07880106
What you commit to
- Study type: Observational
- Planned participants: 2000
- From 1 Oct 2026 to the primary completion date, 30 Jun 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Long-term use of glucocorticoids, immunosuppressants, biologic agents, or psychotropic medications (short-term or as-needed use excepted);
Other illness
- For prospective breast cancer cohorts:
- History of mastitis, or systemic rheumatic/autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis);
- Acute or chronic infectious diseases within the past 6 months (e.g., pneumonia, pulmonary tuberculosis, active hepatitis);
Other
- Inability or refusal to provide informed consent.
Who the study is looking for
- Retrospective pan-cancer cohort:
- Aged 18 to 80 years;
- Both genders
- Clinically and histopathologically confirmed diagnosis of solid malignant tumors, including but not limited to non-small cell lung cancer, colorectal cancer, gastric cancer, hepatocellular carcinoma, or breast cancer.
- Complete clinical data available, including definitive TNM stage and established treatment plan;
- Archived peripheral blood samples (serum/plasma) collected during routine clinical care.
- Prospective neoadjuvant chemotherapy (NAC) breast cancer cohort:
- Female, aged 18 to 80 years (inclusive);
- Clinically and pathologically confirmed non-metastatic (M0) breast cancer;
- Planned standard NAC at the study site, with complete pre-treatment ER, PR, and HER2 immunohistochemistry results available;
- Voluntary participation with signed written informed consent.
- Prospective metastatic breast cancer cohort:
- Female, aged 18 to 80 years (inclusive);
- Clinically and pathologically confirmed metastatic (M1) breast cancer;
- Planned standard systemic therapy at the study site, with complete ER, PR, and HER2 immunohistochemistry results available;
- Voluntary participation with signed written informed consent.
- Benign/Healthy control group:
- Healthy female volunteers, or female patients with breast fibroadenoma undergoing minimally invasive biopsy during the same period;
- Voluntary participation with signed written informed consent.
Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shenshan Medical Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Shanwei | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.