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RECRUITING
NCT07795528

Postoperative Circulating Tumor DNA Monitoring in Stage I-III Driver-Mutant Colon Adenocarcinoma

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

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

OTHER

Longitudinal ctDNA-MRD NGS testing at scheduled postoperative time points

biomarker test only

Locations (1)

Ruijin Hospital North

Shanghai, Shanghai Municipality, China