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 type | Observational |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | City of Hope Medical Center Academic / other |
| Locations | 13 sites (Duarte, California and 12 other locations) |
| Status | Recruiting |
| Started | April 15, 2023 |
| Main results expected | June 18, 2028 |
| Study ends | June 18, 2028 |
| Registry record updated | July 7, 2026 |
| Trial ID | NCT06342401 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
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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
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.