Blood tests to find signs of how breast cancer responds to treatment
Looks for blood markers of treatment response in women with breast cancer.
Plain-language title generated from the registry record
Registry title: Multimodal Liquid-Biopsy Omics Biomarkers of Treatment Response in Breast Cancer
Key facts
- Where
- Shanwei, ChinaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The study includes four groups: adults with solid cancers (retrospective), women with non-metastatic breast cancer about to start chemotherapy before surgery, women with metastatic breast cancer starting standard treatment, and a control group of healthy women or women with a benign breast lump (fibroadenoma).
- Age
- 18 to 80 years.
- Sex
- Both sexes in the retrospective cancer group. Women only in the breast cancer and control groups.
- Disease stage
- Retrospective group: confirmed solid cancer, such as lung, colorectal, stomach, liver or breast cancer. Breast cancer groups: non-metastatic (M0) or metastatic (M1) breast cancer.
- Earlier treatment
- Women in the first breast cancer group must be planning standard chemotherapy before surgery at the study site. Women in the second breast cancer group must be planning standard systemic therapy at the study site.
- Biomarker or test result
- Women with breast cancer must have ER, PR and HER2 test results available. Test results before treatment are needed in the chemotherapy group.
Main reasons for not taking part
- History of mastitis or autoimmune disease such as lupus or rheumatoid arthritis (breast cancer groups)
- Acute or chronic infection in the past 6 months (breast cancer groups)
- Long-term use of glucocorticoids, immunosuppressants, biologic agents or psychotropic medicines (breast cancer groups)
- Unable or unwilling to give informed consent
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07880106, who can take part
Where in China
- Shenshan Medical Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen UniversityShanwei, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Trial code
- NCT07880106
- Record updated
- 19 October 2026
- Original description
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.Read full original descriptionShow less
Exploration of Treatment-Response Biomarkers in Breast Cancer Based on Integrated Liquid-Biopsy Multimodal Omics Features
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.
Inclusion: 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.
Exclusion: Long-term use of glucocorticoids, immunosuppressants, biologic agents, or psychotropic medications (short-term or as-needed use excepted); 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); Inability or refusal to provide informed consent.