NCT06342401Recruiting
Early Onset Colorectal Cancer Detection
Development and Validation fo an Exosome-Based and Machine Learning Powered Liquid Biopsy for the Detection of Early-Onset Colorectal Cancer
Source: ClinicalTrials.gov · Last updated 7 Jul 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 26 Mar 2024
- Start date
- 15 Apr 2023
- Primary completion date
- 18 Jun 2028
- Lead sponsor
- City of Hope Medical Center
- Diseases
- Colorectal cancer
- NCT number
- NCT06342401
What you commit to
- Study type: Observational
- Planned participants: 400
- From 15 Apr 2023 to the primary completion date, 18 Jun 2028
- 13 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Hereditary colorectal cancer syndromes (identified through genetic testing)
- Inflammatory bowel diseases
Other
- Lack of written informed consent
Who the study is looking for
- 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)
Age in the registry: 18 years to 50 years · Sex: All · Accepts healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Surgery Department, Hospital del Mar, Barcelona, Spain Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Barcelona University Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Colorectal Surgery, Vall d'Hebron University Hospital, Universitat Autonoma de Barcelona UAB Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Salamanca Biomedical Research Institute Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| University of Salamanca-SACYL-CSIC, Salamanca, Spain Coordinator of this site? Confirm its status | Salamanca | Spain | Recruiting |
| University of La Laguna Coordinator of this site? Confirm its status | San Cristóbal de La Laguna | Spain | Recruiting |
| IRCCS San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Kawasaki University Coordinator of this site? Confirm its status | Kawasaki | Japan | Recruiting |
| Mie University Coordinator of this site? Confirm its status | Mie | Japan | Recruiting |
| Tokyo Medical and Dental University Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| National Cancer Center Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Yamagata University Coordinator of this site? Confirm its status | Yamagata | Japan | Recruiting |
| City of Hope Medical Center Coordinator of this site? Confirm its status | Duarte | United States | Recruiting |
Related publications
- An Exosome-Based Liquid Biopsy for the Detection of Early-Onset Colorectal Cancer: The ENCODER Multicenter Study.Gastroenterology · 2026 · PMID 41364052
This page is information, not medical advice. Discuss any trial with your doctor.