Clinical trial · Observational
Epigenetic Signature for CRC Early Detection
A Model of Epigenetic Biomarkers Based on cfDNA 5mC/5hmC for Early Detection of Colorectal Cancer
- 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 epiCED is a noninvasive blood-based assay designed for early detection of colorectal cancer (CRC) using circulating cell-free DNA (cfDNA) 5-methylcytosine (5mC) and 5-hydroxymethylcytosine (5hmC) epigenetic markers. This study leverages retrospective, multi-center cohorts of CRC patients and non-cancer controls to discover and validate a robust cfDNA methylation signature. Small-scale sequencing and machine learning-based modeling will be applied to identify a minimal panel of methylation markers that can accurately discriminate CRC from non-cancer individuals, including early-stage disease. The ultimate goal is to develop a clinically practical, noninvasive screening tool that enables population-level early detection and improves patient outcomes.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cell Free DNA | — | UNRESOLVED | — |
| Colorectal Cancer (Diagnosis) | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| DNA Methylation | — | UNRESOLVED | — |
| Early Detection of Cancer | — | UNRESOLVED | — |
| Non-cancer Controls | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- CRC
- description
- Adult patients with confirmed colorectal cancer from international centers.
- label
- Control
- description
- Non-cancer individuals, including healthy volunteers or patients with benign gastrointestinal conditions.
Primary outcomes (1)
- measure
- Sensitivity for detecting colorectal cancer
- timeFrame
- Baseline (pre-treatment blood sample collection)
- description
- Proportion of true positive CRC cases correctly identified by the cfDNA methylation panel.
Secondary outcomes (2)
- measure
- Specificity for detecting colorectal cancer
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults aged ≥18 years at the time of sample collection. * Patients with confirmed CRC or non-cancer controls. * Availability of retrospective blood samples collected according to institutional protocols. * Willingness to allow use of de-identified clinical and demographic data. Exclusion Criteria: * Concurrent malignancies outside the gastrointestinal tract (unless in complete remission ≥5 years). * Samples with insufficient volume or poor cfDNA quality. * Recent chemotherapy, radiotherapy, or major surgery within 4 weeks prior to blood collection (if prospective samples). * Any condition precluding reliable sample analysis or participation.
References
Publications (2)
- BACKGROUNDGoddard KAB, Feuer EJ, Mandelblatt JS, Meza R, Holford TR, Jeon J, Lansdorp-Vogelaar I, Gulati R, Stout NK, Howlader N, Knudsen AB, Miller D, Caswell-Jin JL, Schechter CB, Etzioni R, Trentham-Dietz A, Kurian AW, Plevritis SK, Hampton JM, Stein S, Sun LP, Umar A, Castle PE. Estimation of Cancer Deaths Averted From Prevention, Screening, and Treatment Efforts, 1975-2020. JAMA Oncol. 2025 Feb 1;11(2):162-167. doi: 10.1001/jamaoncol.2024.5381. PMID 39636625
- BACKGROUNDBray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4. PMID 38572751