Postoperative ctDNA Monitoring to Predict Recurrence in Driver-Mutant Stage I-III Colon Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective observational study will enroll up to 392 patients with driver-mutant stage I-III colon adenocarcinoma who have undergone curative resection. Researchers will perform serial ctDNA testing using a standardized 10-gene NGS panel at predefined postoperative time points over 3 years to monitor molecular residual disease. The main goal is to see if postoperative MRD status is associated with recurrence-free survival, with secondary aims including overall survival and timing of recurrence after MRD detection and adjuvant chemotherapy. The study addresses the need for dynamic, real-time risk stratification beyond conventional TNM staging by focusing on driver mutations and serial ctDNA changes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18-75 years, regardless of sex
2. Pathologically confirmed colon adenocarcinoma, clinical stage I-III without preoperative endoscopic submucosal dissection (ESD) or endoscopic mucosal resection (EMR)
3. Planned curative surgical resection, no prior anti-tumor therapy (chemotherapy, radiotherapy, targeted therapy) before surgery
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
5. Tumor tissue positive for at least one driver mutation among KRAS, NRAS, BRAF, PIK3CA
6. Voluntary participation with signed written informed consent, good compliance with scheduled follow-up and blood collection.

Exclusion Criteria:

1. Received neoadjuvant chemotherapy, radiotherapy or targeted therapy before surgery
2. History of other malignant tumors (excluding non-adenomatous colorectal neoplasms)
3. Pregnant or breastfeeding women
4. 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)
5. Abnormal laboratory values or social/family factors judged by investigator to impede sample collection and follow-up
6. Simultaneous participation in other interventional clinical trials with mandatory assigned postoperative treatment regimen

Where it's running

• Ruijin Hospital North
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Ren Zhao, MD, PhD
• Email: zhaorensurgeon@aliyun.com
• Phone: +86 18917762018

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.