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ctDNA-MRD Monitoring for Stage I-III Resectable Colon Adenocarcinoma With Oncogenic Driver Mutations: A Multicenter Prospective Cohort Study

NCT07795528 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 392

Last updated 2026-08-31

No results posted yet for this study

Summary

This is a multicenter, prospective, observational cohort study enrolling 392 patients with stage I-III radically resectable colon adenocarcinoma carrying at least one oncogenic driver mutation (KRAS, NRAS, BRAF, PIK3CA). Serial plasma ctDNA-MRD testing via a standardized 10-gene NGS panel will be performed at predefined time points during 3-year postoperative follow-up. The primary objective is to evaluate the correlation between postoperative ctDNA-MRD status and recurrence-free survival (RFS). Secondary objectives include overall survival (OS), time advantage of MRD for early recurrence warning ahead of radiology, and correlation between dynamic MRD changes and adjuvant treatment efficacy. Exploratory analysis will compare MRD detection rate and prognostic performance across distinct driver mutation subtypes, aiming to build an integrated risk stratification model combining driver genotype and longitudinal MRD monitoring to guide individualized adjuvant therapy for colon cancer patients.

Conditions

  • Colon Adenocarcinoma
  • Stage I Colon Cancer
  • Stage II Colon Cancer
  • Stage III Colon Cancer

Interventions

OTHER

Longitudinal ctDNA-MRD NGS testing at scheduled postoperative time points

biomarker test only

Sponsors & Collaborators

  • The First Hospital of Jilin University

    collaborator OTHER

  • Ruijin Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-14
Primary Completion
2030-12-31
Completion
2030-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07795528 on ClinicalTrials.gov