Clinical trial · Observational
ctDNA Methylation Application in Postoperative Relapse and Adjuvant Chemotherapy Efficacy Evaluation
ctDNA Methylation Used to Monitor Postoperative Relapse and Evaluate Adjuvant Chemotherapy Efficacy in Resected Stage I and Stage II (Without High Risk) Colorectal Cancer After Radical Resection
NCT05536089CI-TRIAL-00077385recruitingClinicalTrials.gov clinicaltrialsProvenance
- 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)
In this study, the investigators aimed to apply their previously developed multi-locus blood-based assay targeting circulating tumor DNA methylation to monitor postoperative relapse and evaluate adjuvant chemotherapy efficacy in resected stage I and stage II (without high risk) colorectal cancer after radical resection.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Colorectal | Colon Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| a multi-locus blood-based assay | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- ctDNA positive
- description
- Postoperative ctDNA positive
- interventionNames
- Diagnostic Test: a multi-locus blood-based assay
- label
- ctDNA negative
- description
- Postoperative ctDNA negative
- interventionNames
- Diagnostic Test: a multi-locus blood-based assay
Primary outcomes (2)
- measure
- 5y DFS
- timeFrame
- 5 years
- description
- The 5-year disease free survival rate of the patients from both cohorts.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have histologically confirmed stage I/II (without high risk) colorectal cancer. * Male or female ≥ 18 years of age on the day of signing informed consent. * Patients need to receive surgical resection, and with ctDNA positive prior to resection of colorectal cancer (CRC). * Patients must have a performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale. * Written informed consent must be obtained from patient or patient's legal representative and ability for patient to comply with the requirements of the study. Exclusion Criteria: * Personal history of colorectal cancer, colorectal adenoma or aerodigestive tract cancer. * Induction of neoadjuvant systemic therapy prior to resection of CRC. * Patient is pregnant or lactating. * Patients with a history or current evidence of any condition or abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the Investigator. * Inadequate tumor material (either quality and quantity) to support circulating tumor DNA (ctDNA) analysis.
References
Publications (1)
- RESULTCai G, Cai M, Feng Z, Liu R, Liang L, Zhou P; ColonAiQ Group; Zhu B, Mo S, Wang H, Lan X, Cai S, Xu Y, Wang R, Dai W, Han L, Xiang W, Wang B, Guo W, Zhang L, Zhou C, Luo B, Li Y, Nie Y, Ma C, Su Z. A Multilocus Blood-Based Assay Targeting Circulating Tumor DNA Methylation Enables Early Detection and Early Relapse Prediction of Colorectal Cancer. Gastroenterology. 2021 Dec;161(6):2053-2056.e2. doi: 10.1053/j.gastro.2021.08.054. Epub 2021 Sep 4. No abstract available. PMID 34487783