Early Onset Colorectal Cancer Detection (ENCODE)

January 27, 2026 updated by: City of Hope Medical Center

Development and Validation fo an Exosome-Based and Machine Learning Powered Liquid Biopsy for the Detection of Early-Onset Colorectal Cancer

Colorectal cancer (CRC) once predominantly affected older individuals, but in recent years has witnessed a progressive increase in incidence among young adults. Once rare, early-onset colorectal cancer (EOCRC, that is, a CRC diagnosed before the age of 50) now constitutes 10-15% of all newly diagnosed CRC cases and it stands as the first cause of cancer-related death in young men and the second for young women.

This study aims to detect EOCRC with a non-invasive test, using a blood-based molecular assay based on microRNA (ribonucleic acid)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The rising incidence of early-onset colorectal cancer (EOCRC) is a pressing clinical issue unique to our times, and it is expected to grow with an anticipated further 90% increase in incidence by the decade's end. Challenges persist even after reducing the CRC screening age to 45: under-45s lack routine screening and compliance in the 45-50 age group remains low, partly due to invasiveness and discomfort of standard screening methods. Urgent action is warranted to develop affordable, sensitive, and feasible screening for timely detection and improved participation. A non-invasive, patient-friendly screening test, like a blood-based assay, could address these epidemiological concerns and also attract underserved populations.

This study involves the development and validation of a liquid biopsy, assessing circulating cell-free and exosomal microRNAs (cf-miRNA and exo-miRNA, respectively) for indirect sampling of tumor tissue in the bloodstream. The researchers intend to harness machine learning and bioinformatics to create an integrated panel (with both cf-miRNAs and exo-miRNAs) to enhance the inherently high sensitivity of cf-miRNAs with the distinctive specificity of exo-miRNAs. This combined approach will not only improve the performance of a diagnostic model but will also tap into the diverse tumor biology aspects of EOCRC.

The study's core goal is to develop cost-efficient, non-invasive, clinic-friendly biomarkers with high sensitivity and specificity, aiding EOCRC detection.

The researchers intend to do so in three phases:

  1. To perform comprehensive small RNA-Seq from matched cf-miRNA, exo-miRNA, cancer-derived miRNA, and mucosa-derived miRNA.
  2. To develop and train two miRNA detection panels (cf-miRNA and exo-miRNA, respectively) based on advanced machine-learning models and, then, combine these two using several machine-learning models to obtain a final detection biomarker.
  3. To validate the findings in an independent cohort of EOCRC and controls.

In summary, this proposal promises to improve patient care and compliance, and, ultimately, reduce mortality from EOCRC.

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ajay Goel, PhD
  • Phone Number: 626-218-3452
  • Email: AJGOEL@COH.ORG

Study Locations

  • Italy
      • Milan, Italy
        • Recruiting
        • IRCCS San Raffaele
        • Principal Investigator:
          • Alessandro Mannucci, MD
        • Contact:
        • Principal Investigator:
          • Giulia Martina Cavestro, MD, PhD
  • Japan
      • Kawasaki, Japan
        • Recruiting
        • Kawasaki University
      • Mie, Japan
        • Recruiting
        • Mie University
      • Tokyo, Japan
        • Recruiting
        • National Cancer Center Hospital
      • Tokyo, Japan
        • Recruiting
        • Tokyo Medical and Dental University
      • Yamagata, Japan
        • Recruiting
        • Yamagata University
  • Spain
      • Barcelona, Spain
        • Recruiting
        • Barcelona University
        • Contact:
      • Barcelona, Spain
        • Recruiting
        • Colorectal Surgery, Vall d'Hebron University Hospital, Universitat Autonoma de Barcelona UAB
        • Contact:
      • Barcelona, Spain
        • Recruiting
        • Surgery Department, Hospital del Mar, Barcelona, Spain
        • Contact:
      • Madrid, Spain
        • Recruiting
        • Salamanca Biomedical Research Institute
        • Contact:
        • Sub-Investigator:
          • Jose Perea, MD
      • Salamanca, Spain
        • Recruiting
        • University of Salamanca-SACYL-CSIC, Salamanca, Spain
        • Contact:
      • San Cristóbal de La Laguna, Spain
        • Recruiting
        • University of La Laguna
  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope Medical Center
        • Contact:
        • Principal Investigator:
          • Alessandro Mannucci, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Individuals younger than 50 years of age who were diagnosed with colorectal cancer before the age of 50 (cases) or were free from colorectal cancer at the time of study inclusion (controls)

Description

Inclusion Criteria:

  • Stage I, II, III, IV colorectal cancer (TNM classification, 8th edition) diagnosed before the age of 50 (EOCRC cases)
  • Received standard diagnostic and staging procedures as per local guidelines, and at least one sample was drawn before receiving any curative-intent treatment
  • Colonoscopy-proven cancer-free status at the time of study inclusion (Non-disease controls)

Exclusion Criteria:

  • Hereditary colorectal cancer syndromes (identified through genetic testing)
  • Inflammatory bowel diseases
  • Lack of written informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Early onset colorectal cancer (Training cohort)
Colorectal cancer diagnosed before the age of 50
Diagnostic test: ENCODE
A panel of microRNA, both cell-free and exosomes, whose expression level is tested from plasma samples from patients with early onset colorectal cancer and non-disease controls.
Other Names:
  • ENCODE (Early oNset COlorectal cancer DEtection)
Non-disease controls (Training cohort)
Individuals free from colorectal cancer, younger than 50 years of age
Diagnostic test: ENCODE
A panel of microRNA, both cell-free and exosomes, whose expression level is tested from plasma samples from patients with early onset colorectal cancer and non-disease controls.
Other Names:
  • ENCODE (Early oNset COlorectal cancer DEtection)
Early onset colorectal cancer (Validation cohort)
Colorectal cancer diagnosed before the age of 50
Diagnostic test: ENCODE
A panel of microRNA, both cell-free and exosomes, whose expression level is tested from plasma samples from patients with early onset colorectal cancer and non-disease controls.
Other Names:
  • ENCODE (Early oNset COlorectal cancer DEtection)
Non-disease controls (Validation cohort)
Individuals free from colorectal cancer, younger than 50 years of age
Diagnostic test: ENCODE
A panel of microRNA, both cell-free and exosomes, whose expression level is tested from plasma samples from patients with early onset colorectal cancer and non-disease controls.
Other Names:
  • ENCODE (Early oNset COlorectal cancer DEtection)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity
Time Frame: Through study completion, an average of 1 year
True Positive Rate: the probability of a positive test result, conditioned on the individual truly being positive
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of correct predictions (true positives and true negatives) among the total cases (i.e., accuracy)
Time Frame: Through study completion, an average of 1 year
A measure of trueness: proportion of correct predictions (both true positives and true negatives) among the total number of cases examined
Through study completion, an average of 1 year
Specificity
Time Frame: Through study completion, an average of 1 year
True Negative Rate: the probability of a negative test result, conditioned on the individual truly being negative
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Investigators

  • Principal Investigator: Ajay Goel, PhD, City of Hope Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2023

Primary Completion (Estimated)

June 18, 2026

Study Completion (Estimated)

June 18, 2026

Study Registration Dates

First Submitted

March 26, 2024

First Submitted That Met QC Criteria

April 1, 2024

First Posted (Actual)

April 2, 2024

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23228/ENCODE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data collected for the study will be made available to others, including de-identified participant data, at publication, via a signed data access agreement and at the discretion of the investigators' approval of the proposed use of such data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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