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Postoperative Circulating Tumor DNA Monitoring in Stage I-III Driver-Mutant Colon Adenocarcinoma
Sponsor: Ruijin Hospital
Summary
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.
Official title: Multicenter Prospective Cohort Study of Molecular Residual Disease (MRD) in Stage I-III Surgically Resectable Colon Adenocarcinoma Harboring Oncogenic Driver Mutations
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
OBSERVATIONAL
Enrollment
392
Start Date
2026-08-14
Completion Date
2030-12-31
Last Updated
2026-09-02
Healthy Volunteers
No
Interventions
Longitudinal ctDNA-MRD NGS testing at scheduled postoperative time points
biomarker test only
Locations (1)
Ruijin Hospital North
Shanghai, Shanghai Municipality, China