Early Onset Colorectal Cancer Detection

Last updated: May 1, 2025
Sponsor: City of Hope Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colon Cancer

Colon Cancer; Rectal Cancer

Colorectal Cancer

Treatment

ENCODE

Clinical Study ID

NCT06342401
23228/ENCODE
  • Ages 18-50
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Stage I, II, III, IV colorectal cancer (TNM classification, 8th edition) diagnosedbefore the age of 50 (EOCRC cases)

  • Received standard diagnostic and staging procedures as per local guidelines, and atleast one sample was drawn before receiving any curative-intent treatment

  • Colonoscopy-proven cancer-free status at the time of study inclusion (Non-diseasecontrols)

Exclusion

Exclusion Criteria:

  • Hereditary colorectal cancer syndromes (identified through genetic testing)

  • Inflammatory bowel diseases

  • Lack of written informed consent

Study Design

Total Participants: 400
Treatment Group(s): 1
Primary Treatment: ENCODE
Phase:
Study Start date:
April 15, 2023
Estimated Completion Date:
October 15, 2025

Study 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.

Connect with a study center

  • IRCCS San Raffaele

    Milan,
    Italy

    Active - Recruiting

  • Kawasaki University

    Kawasaki,
    Japan

    Active - Recruiting

  • Mie University

    Mie,
    Japan

    Active - Recruiting

  • National Cancer Center Hospital

    Tokyo,
    Japan

    Active - Recruiting

  • Tokyo Medical and Dental University

    Tokyo,
    Japan

    Active - Recruiting

  • Yamagata University

    Yamagata,
    Japan

    Active - Recruiting

  • Barcelona University

    Barcelona,
    Spain

    Active - Recruiting

  • Colorectal Surgery, Vall d'Hebron University Hospital, Universitat Autonoma de Barcelona UAB

    Barcelona,
    Spain

    Active - Recruiting

  • Surgery Department, Hospital del Mar, Barcelona, Spain

    Barcelona,
    Spain

    Active - Recruiting

  • University of La Laguna

    La Laguna,
    Spain

    Active - Recruiting

  • Salamanca Biomedical Research Institute

    Madrid,
    Spain

    Active - Recruiting

  • University of Salamanca-SACYL-CSIC, Salamanca, Spain

    Salamanca,
    Spain

    Active - Recruiting

  • City of Hope Medical Center

    Duarte, California 91010
    United States

    Active - Recruiting

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