Clinical trial Recruiting at 13 sites Observational Ages 18 to 50

Detecting early onset colorectal cancer using a blood test

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

Run by City of Hope Medical Center · NCT06342401 · Data updated 2026-11-12

This study is testing a new blood test that looks for specific markers to help find early signs of colorectal cancer in young adults.

Quick facts

Study typeObservational
Ages18 Years to 50 Years
SexAll
Enrollment400 (estimated)
SponsorCity of Hope Medical Center
Academic / other
Locations13 sites (Duarte, California and 12 other locations)
StatusRecruiting
StartedApril 15, 2023
Main results expectedJune 18, 2028
Study endsJune 18, 2028
Registry record updatedJuly 7, 2026
Trial IDNCT06342401 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals diagnosed with stage I to IV colorectal cancer before the age of 50.

Probably not a fit

Patients with hereditary colorectal cancer syndromes or inflammatory bowel diseases may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on the rising incidence of early-onset colorectal cancer (EOCRC) among young adults, aiming to develop a non-invasive blood-based molecular assay utilizing microRNA for detection. The study will assess circulating cell-free and exosomal microRNAs to create a diagnostic model that enhances sensitivity and specificity for EOCRC. By employing machine learning and bioinformatics, the researchers intend to establish cost-effective and patient-friendly biomarkers that can improve screening participation among underserved populations. The ultimate goal is to facilitate timely detection of EOCRC, addressing a significant public health concern.

Why it matters

Potential benefit: If successful, this study could provide a non-invasive and effective screening method for early detection of colorectal cancer in young adults.

How similar studies have gone: While the approach of using microRNA for cancer detection is promising, this specific application for early-onset colorectal cancer is relatively novel and has not been extensively tested in prior studies.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • City of Hope Medical Center
    Duarte, California, United States
    Recruiting
  • IRCCS San Raffaele
    Milan, Italy
    Recruiting
  • Kawasaki University
    Kawasaki, Japan
    Recruiting
  • Mie University
    Mie, Japan
    Recruiting
  • National Cancer Center Hospital
    Tokyo, Japan
    Recruiting
  • Tokyo Medical and Dental University
    Tokyo, Japan
    Recruiting
Show 7 more locations
  • Yamagata University
    Yamagata, Japan
    Recruiting
  • Barcelona University
    Barcelona, Spain
    Recruiting
  • Colorectal Surgery, Vall d'Hebron University Hospital, Universitat Autonoma de Barcelona UAB
    Barcelona, Spain
    Recruiting
  • Surgery Department, Hospital del Mar, Barcelona, Spain
    Barcelona, Spain
    Recruiting
  • Salamanca Biomedical Research Institute
    Madrid, Spain
    Recruiting
  • University of Salamanca-SACYL-CSIC, Salamanca, Spain
    Salamanca, Spain
    Recruiting
  • University of La Laguna
    San Cristóbal de La Laguna, Spain
    Recruiting

Study contacts

  • Principal investigator: Ajay Goel, PhD — City of Hope Medical Center
  • Study coordinator: Ajay Goel, PhD
  • Email: AJGOEL@COH.ORG
  • Phone: 626-218-3452

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.