Detecting early onset colorectal cancer using a blood test
Development and Validation fo an Exosome-Based and Machine Learning Powered Liquid Biopsy for the Detection of Early-Onset Colorectal Cancer
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 |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | City of Hope Medical Center Academic / other |
| Locations | 13 sites (Duarte, California and 12 other locations) |
| Trial ID | NCT06342401 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with stage I to IV colorectal cancer before the age of 50.
Not a fit: Patients with hereditary colorectal cancer syndromes or inflammatory bowel diseases may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Duarte, California and 12 other locations
- 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)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.