Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Adenocarcinoma | Colon Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Stage I Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Longitudinal ctDNA-MRD NGS testing at scheduled postoperative time points | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Driver-mutant Stage I-III Resectable Colon Adenocarcinoma Cohort
- description
- Patients pathologically diagnosed with stage I-III colon adenocarcinoma, curatively resected, carrying ≥1 oncogenic driver mutation (KRAS/NRAS/BRAF/PIK3CA), aged 18-75 years, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, without prior neoadjuvant therapy or other synchronous malignancy. All patients receive standard clinical surveillance plus serial blood draws for ctDNA-based MRD testing as observational biomarker testing only; no experimental treatment is assigned by the study protocol.
- interventionNames
- Other: Longitudinal ctDNA-MRD NGS testing at scheduled postoperative time points
Primary outcomes (1)
- measure
- Correlation between postoperative ctDNA-MRD status and Recurrence-Free Survival (RFS)
- timeFrame
- 3 years post curative resection
- description
- RFS is defined as time from curative surgery to radiology/pathology-confirmed recurrence/metastasis, all-cause death, or last follow-up (whichever occurs first). Evaluate statistical association between MRD positive/negative status and RFS via survival analysis.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (5)
- BACKGROUNDTie J, et al. Circulating tumor DNA dynamics predict recurrence and adjuvant chemotherapy benefit in colorectal cancer. N Engl J Med. 2020;382(6):545-555.
- BACKGROUNDLiu Y, et al. Genomic characteristics of resectable colorectal cancer and their impact on ctDNA MRD detection. Clin Cancer Res. 2025;31(12):2456-2467.
- BACKGROUNDBESPOKE Study Group. ctDNA MRD predicts recurrence and adjuvant chemotherapy benefit in stages II-III colorectal cancer. Lancet Oncol. 2025;26(5):689-701.
- BACKGROUNDChinese Society of Pathology; Pathology Quality Control Center; Colorectal Cancer Expert Committee of Chinese Society of Clinical Oncology (CSCO). [Clinical practice guideline for molecular pathology in colorectal cancer (2025 version)]. Zhonghua Bing Li Xue Za Zhi. 2025 May 8;54(5):448-462. doi: 10.3760/cma.j.cn112151-20241206-00827. Chinese. PMID 40302573
- BACKGROUNDSung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID 33538338