An observational study in Lung Cancer Non-small Cell, Colorectal Cancer and Stomach Cancer, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Observational
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.
Peripheral blood (20 mL) is collected at protocol-defined time points. Serum/Plasma autoantibody repertoires are profiled by PhIP-seq(phage-display immunoprecipitation sequencing); cfDNA methylation is measured by bisulfite-free methylome profiling; exosome RNA is profiled by strand-specific RNA sequencing; and untargeted plasma metabolomics is performed by liquid chromatography-tandem mass spectrometry. The study endpoints include clinical response and pathological complete response after NAC, together with survival follow-up. The study is conducted in accordance with the Declaration of Helsinki and Chinese regulations for investigator-initiated research, and has been approved by the institutional ethics committee.
Ambispective - a retrospective pan-cancer cohort (archived samples, 2020 Jan - 2026. Sep) combined with prospective breast cancer cohorts (enrollment 2026. Oct -2029)
6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 164 across 974 observational studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 477 studies on the registry; 278 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Study participants will be selected from three main sources: (1) healthy female volunteers recruited for this study; (2) patients receiving clinical treatment at our institution; and (3) patients undergoing relevant diagnostic or clinical examinations at our institution.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Retrospective pan-cancer cohort:
Prospective neoadjuvant chemotherapy (NAC) breast cancer cohort:
Prospective metastatic breast cancer cohort:
Benign/Healthy control group:
Exclusion Criteria:
For prospective breast cancer cohorts:
Patients aged 18-80 years with histologically confirmed solid malignant tumors( e.g. non-small cell lung cancer, colorectal cancer, gastric cancer, hepatocellular carcinoma, or breast cancer), diagnosed at the study site between January 2020 and Sep 2026, with complete clinical data (TNM stage and treatment plan) and archived residual serum/plasma samples. Approximately 1,000 cases.
Women aged 18-80 years with clinically and pathologically confirmed non-metastatic (M0) breast cancer who plan to receive standard NAC at the study site, with complete pre-treatment ER, PR, and HER2 immunohistochemistry results. Planned enrollment: 800. Peripheral blood (20 mL) is collected before, during, and after NAC (pre-surgery), in addition to routine clinical data.
Patients with breast fibroadenoma undergoing minimally invasive biopsy during the same period, serving as benign controls to calibrate background signals of circulating antigens and liquid-biopsy analytes. Healthy female volunteers will also be enrolled. Planned enrollment: 100.
Women aged 18-80 years with clinically and pathologically confirmed metastatic (M1) breast cancer who plan to receive standard systemic therapy at the study site, with complete ER, PR, and HER2 immunohistochemistry results.Planned enrollment: 100. Serial peripheral blood samples are collected before, during, and after treatment.
Pathological Complete Response (pCR) Rate
Proportion of patients achieving pCR after completion of neoadjuvant chemotherapy, defined as ypT0/is ypN0 (no invasive cancer in the breast and ipsilateral axillary lymph nodes; ductal carcinoma in situ may be present), consistent with RCB-0.
Time frame: At definitive surgery after completion of NAC (approximately 4-6 months after NAC initiation)
Residual Cancer Burden (RCB) Class
RCB class (RCB-0, RCB-I, RCB-II, RCB-III) quantifying residual tumor in the breast and lymph nodes after neoadjuvant therapy, calculated using the internationally validated MD Anderson Cancer Center RCB calculator based on standardized pathological assessment of surgical specimens.
Time frame: At definitive surgery after completion of NAC (approximately 4-6 months after NAC initiation)
Invasive Disease-Free Survival (iDFS)
Time from enrollment to the first occurrence of any of the following: ipsilateral invasive breast cancer recurrence, contralateral invasive breast cancer, distant metastasis, second primary non-breast invasive malignancy, or death from any cause (conservative definition including all deaths), per established consensus definitions. Follow-up includes clinical visits and imaging (breast ultrasound/MRI, chest-abdominal CT, bone scan as risk-stratified) every 6 months.
Time frame: From enrollment until event or study end, assessed every 6 months (up to approximately 5 years)
Progression-Free Survival (PFS)
Time from enrollment to the first radiographically confirmed disease progression (per RECIST 1.1) or death from any cause. This outcome is only available for M1 patients.
Time frame: From enrollment until event or study end (up to approximately 5 years)
Overall Survival (OS)
Time from enrollment to death from any cause. Death events are confirmed by death certificates, hospital records, or national vital registration systems. Patients lost to follow-up are censored at the date of last contact.
Time frame: From enrollment until death or study end (up to approximately 5 years or longer)
Plan to share: Undecided — De-identified individual participant data may be made available upon reasonable request to the corresponding investigator after publication of the primary results, subject to institutional and ethics committee approval.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Jun 2030, 44 months later.
Of 312 non-industry observational studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 155. This study's planned 44 months is below that.
Counting every sponsor, half of 440 studies reached it within 56 months; a quarter within 36 and three quarters within 89.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Carcinoma, Non-Small-Cell Lung →
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University →