Epigenetic Signature for CRC Early Detection

NCT07224854 | Active Not Recruiting

• 1 other identifier: 23228/epiCED
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Colorectal Cancer (Diagnosis); Non-cancer Controls; DNA Methylation; Cell Free DNA; Early Detection of Cancer

Keywords

noninvasive screening; circulating cfDNA; 5mC; 5hmC; epigenetic biomarkers; machine learning; colorectal cancer; early detection

Outcome Measures

Primary Outcomes (1)

• Sensitivity for detecting colorectal cancer

  Proportion of true positive CRC cases correctly identified by the cfDNA methylation panel.

  Baseline (pre-treatment blood sample collection)

Secondary Outcomes (2)

• Specificity for detecting colorectal cancer

  Frame: Baseline (pre-treatment blood sample collection)

• Area Under the Receiver Operating Characteristic Curve (AUROC)

  Baseline (pre-treatment blood sample collection)

Study Arms (2)

CRC

Adult patients with confirmed colorectal cancer from international centers.

Control

Non-cancer individuals, including healthy volunteers or patients with benign gastrointestinal conditions.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Retrospective, international multi-center cohort of adults (≥18 years), including CRC patients and non-cancer controls. Blood samples and corresponding de-identified clinical data are available for discovery, model training, and multi-center validation.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• City of Hope Medical Center: lead

Study Sites (1)

City of Hope Nat Medical Ctr

Monrovia, California, 91016, United States

Location

Related Publications (2)

• Goddard 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 BACKGROUND

• Bray 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 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms; Disease

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ajay Goel, PhD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2025
• First Posted: November 5, 2025
• Study Start: June 21, 2024
• Primary Completion (Estimated): June 18, 2026
• Study Completion (Estimated): June 18, 2026
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)