Postoperative Circulating Tumor DNA Monitoring in Stage I-III Driver-Mutant Colon Adenocarcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorRuijin Hospital
About this trial
This multicenter prospective observational cohort study will enroll 392 patients with stage I-III colon adenocarcinoma who undergo curative resection and whose tumors harbor at least one prespecified oncogenic driver mutation (KRAS, NRAS, BRAF, or PIK3CA). Serial plasma circulating tumor DNA (ctDNA) testing for molecular residual disease (MRD) will be performed with a standardized 10-gene next-generation sequencing (NGS) panel at predefined time points during 3 years of postoperative follow-up. The primary objective is to evaluate the association between postoperative ctDNA-based MRD status and recurrence-free survival (RFS). Secondary objectives include evaluating overall survival (OS), the interval between first MRD detection and radiologically confirmed recurrence, and the association between longitudinal MRD changes and outcomes following adjuvant chemotherapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-75 years, regardless of sex
Pathologically confirmed colon adenocarcinoma, clinical stage I-III without preoperative endoscopic submucosal dissection (ESD) or endoscopic mucosal resection (EMR)
Planned curative surgical resection, no prior anti-tumor therapy (chemotherapy, radiotherapy, targeted therapy) before surgery
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Disqualifiers
Received neoadjuvant chemotherapy, radiotherapy or targeted therapy before surgery
History of other malignant tumors (excluding non-adenomatous colorectal neoplasms)
Pregnant or breastfeeding women
Severe concurrent systemic diseases that interfere with long-term follow-up or short-term survival (uncontrolled severe infection, organ failure, mental disorders, or other serious conditions)
Trial population
Patients will be selected from consecutive adults evaluated for curative-intent surgery for pathologically confirmed stage I-III colon adenocarcinoma at 10 participating tertiary hospitals in China with colorectal surgery and molecular pathology capabilities. The study cohort will include eligible patients aged 18-75 years whose tumor tissue harbors at least one prespecified oncogenic driver mutation and who consent to serial postoperative blood collection and 3 years of follow-up.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Longitudinal ctDNA-MRD NGS testing at scheduled postoperative time points
Other interventionbiomarker test only
Treatment groups
392 Participants
are divided into 1 treatment groupGroup A: Driver-mutant Stage I-III Resectable Colon Adenocarcinoma Cohort1 intervention
Trial outcomes
Primary outcomes
1
Correlation between postoperative ctDNA-MRD status and Recurrence-Free Survival (RFS)
RFS is defined as time from curative surgery to radiology/pathology-confirmed recurrence/metastasis, all-cause death, or last follow-up (whichever occurs first). Evaluate statistical association between MRD positive/negative status and RFS via survival analysis.
Time frame
3 years post curative resectionSecondary outcomes
1
Correlation between ctDNA-MRD status and Overall Survival (OS)
OS defined as time from enrollment to all-cause death; compare OS between MRD-positive and MRD-negative subgroups
Time frame
3 years post curative resection2
Median lead time of MRD positivity prior to radiologically confirmed tumor recurrence
Calculate average interval between first detectable ctDNA-MRD and CT-verified disease relapse to quantify early warning advantage of MRD surveillance
Time frame
Up to 3 years postoperative follow-up3
Association between dynamic ctDNA-MRD changes and adjuvant chemotherapy efficacy
Analyze clinical outcome across MRD trajectory subgroups: sustained negative, intermittent positive, sustained positive, seroconversion from negative to positive
Time frame
3 years post curative resectionOther outcomes
1
MRD positive detection rate stratified by distinct oncogenic driver mutation subtypes
Compare MRD detectability among driver gene mutant subgroups
Time frame
All serial blood testing time points within 3-year follow-up2
Prognostic predictive performance of ctDNA-MRD across different driver mutation subtypes
Evaluate heterogeneity of MRD's hazard ratio for recurrence among separate driver mutant cohorts
Time frame
3 years post curative resectionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ruijin Hospital
Lead sponsor
The First Hospital of Jilin University
Collaborator
Source ClinicalTrials.gov