NCT07795528Recruiting
Postoperative Circulating Tumor DNA Monitoring in Stage I-III Driver-Mutant Colon Adenocarcinoma
Multicenter Prospective Cohort Study of Molecular Residual Disease (MRD) in Stage I-III Surgically Resectable Colon Adenocarcinoma Harboring Oncogenic Driver Mutations
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 392 (estimated)
- First submitted
- 23 Aug 2026
- Start date
- 14 Aug 2026
- Primary completion date
- 31 Dec 2030
- Lead sponsor
- Ruijin Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT07795528
What you commit to
- Study type: Observational
- Planned participants: 392
- From 14 Aug 2026 to the primary completion date, 31 Dec 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received neoadjuvant chemotherapy, radiotherapy or targeted therapy before surgery
- 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)
Other illness
- History of other malignant tumors (excluding non-adenomatous colorectal neoplasms)
Lab values
- Abnormal laboratory values or social/family factors judged by investigator to impede sample collection and follow-up
Other
- Pregnant or breastfeeding women
- Simultaneous participation in other interventional clinical trials with mandatory assigned postoperative treatment regimen
Who the study is looking for
- 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
- Tumor tissue positive for at least one driver mutation among KRAS, NRAS, BRAF, PIK3CA
- Voluntary participation with signed written informed consent, good compliance with scheduled follow-up and blood collection.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ruijin Hospital North Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.