Clinical trial · Observational
cfDNA 5mC/5hmC Biomarkers to Predict Chemotherapy Response in Metastatic Colorectal Cancer
Development of a cfDNA 5mC/5hmC-based Epigenetic Biomarker Panel to Predict Chemotherapy Efficacy in Metastatic Colorectal Cancer
NCT07224815CI-TRIAL-00117076EpiCORErecruitingClinicalTrials.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)
The EpiCORE study aims to identify cfDNA-based epigenetic markers predictive of response to first-line chemotherapy (FOLFOX or FOLFIRI) in metastatic colorectal cancer (mCRC). By integrating 5-methylcytosine (5mC) and 5-hydroxymethylcytosine (5hmC) profiling, this study seeks to establish a non-invasive biomarker panel capable of distinguishing responders from non-responders.
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 |
|---|---|---|---|
| CRC (Colorectal Cancer) | Colorectal Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cfDNA 5mC/5hmC Sequencing (EpiCORE Discovery Phase) | Diagnostic Test | — | UNRESOLVED |
| EpiCORE Assay (Targeted Sequencing / qPCR Validation) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- label
- Discovery Cohort - PFS ≥ 12 Months (Responder)
- description
- Patients with mCRC who achieved progression-free survival ≥ 12 months after first-line chemotherapy (FOLFOX or FOLFIRI). cfDNA 5mC/5hmC sequencing performed to identify epigenetic determinants of durable response.
- interventionNames
- Diagnostic Test: cfDNA 5mC/5hmC Sequencing (EpiCORE Discovery Phase)
- label
- Discovery Cohort - PFS < 12 Months (Non-Responder)
- description
- Patients with progression-free survival \< 12 months after first-line chemotherapy. Compared with responders to identify epigenetic features associated with resistance.
- interventionNames
- Diagnostic Test: cfDNA 5mC/5hmC Sequencing (EpiCORE Discovery Phase)
- label
- Training Cohort - PFS ≥ 12 Months (Responder)
- description
- Independent mCRC cohort with long PFS (≥12M). Targeted sequencing (EpiCORE assay) to refine predictive markers.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed metastatic colorectal adenocarcinoma (mCRC). * Received first-line chemotherapy (FOLFOX or FOLFIRI). * Availability of pre-treatment serum or plasma samples for cfDNA 5mC/5hmC analysis. * Documented radiologic or clinical response evaluation (RECIST 1.1 or PFS-based). * RAS/BRAF mutation status available. Exclusion Criteria: * Inadequate cfDNA yield or poor DNA quality. * Non-adenocarcinoma histology. * Active inflammatory or autoimmune disease that may alter cfDNA methylation. * Concomitant malignancy requiring systemic therapy.
References
Publications (17)
- BACKGROUNDNelson MA, Shetty S, Kulakodlu M, Harley C, Seal B. A comparison of mortality and costs associated with FOLFOX versus FOLFIRI in stage IV colorectal cancer. J Med Econ. 2011;14(2):179-86. doi: 10.3111/13696998.2011.556693. Epub 2011 Feb 14. PMID 21319948
- BACKGROUNDBond MJG, Bolhuis K, Loosveld OJL, de Groot JWB, Droogendijk H, Helgason HH, Hendriks MP, Klaase JM, Kazemier G, Liem MSL, Rijken AM, Verhoef C, de Wilt JHW, de Jong KP, Gerhards MF, van Amerongen MJ, Engelbrecht MRW, van Lienden KP, Molenaar IQ, de Valk B, Haberkorn BCM, Kerver ED, Erdkamp F, van Alphen RJ, Mathijssen-van Stein D, Komurcu A, Lopez-Yurda M, Swijnenburg RJ, Punt CJA; Dutch Colorectal Cancer Study Group. First-line systemic treatment strategies in patients with initially unresectable colorectal cancer liver metastases (CAIRO5): an open-label, multicentre, randomised, controlled, phase 3 study from the Dutch Colorectal Cancer Group. Lancet Oncol. 2023 Jul;24(7):757-771. doi: 10.1016/S1470-2045(23)00219-X. Epub 2023 Jun 14. PMID 37329889
- BACKGROUNDBond MJG, Bolhuis K, Loosveld OJL, de Groot JWB, Droogendijk H, Helgason HH, Hendriks MP, Klaase JM, Kazemier G, Liem MSL, Rijken AM, Verhoef C, de Wilt JHW, de Jong KP, Gerhards MF, van Amerongen MJ, Engelbrecht MRW, van Lienden KP, Hermans JJ, Molenaar IQ, Grunhagen DJ, de Valk B, Haberkorn BCM, Kerver ED, Erdkamp F, van Alphen RJ, Mathijssen-van Stein D, Komurcu A, May AM, Swijnenburg RJ, Punt CJA; Dutch Colorectal Cancer Group. First-Line Systemic Treatment for Initially Unresectable Colorectal Liver Metastases: Post Hoc Analysis of the CAIRO5 Randomized Clinical Trial. JAMA Oncol. 2025 Jan 1;11(1):36-45. doi: 10.1001/jamaoncol.2024.5174. PMID 39570583
- BACKGROUNDNeugut AI, Lin A, Raab GT, Hillyer GC, Keller D, O'Neil DS, Accordino MK, Kiran RP, Wright J, Hershman DL. FOLFOX and FOLFIRI Use in Stage IV Colon Cancer: Analysis of SEER-Medicare Data. Clin Colorectal Cancer. 2019 Jun;18(2):133-140. doi: 10.1016/j.clcc.2019.01.005. Epub 2019 Jan 31. PMID 30878317
- BACKGROUNDGibbons CE, Khan F. Dysphagia--a presenting symptom of forestier disease. J R Army Med Corps. 1996 Feb;142(1):32-3. doi: 10.1136/jramc-142-01-07.