RecruitingNCT06342401

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


Sponsor

City of Hope Medical Center

Enrollment

400 participants

Start Date

Apr 15, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study aims to develop and improve blood-based tests (liquid biopsy) to detect colorectal cancer that starts at a young age — specifically in people diagnosed before age 50, which is called early-onset colorectal cancer (EOCRC). **You may be eligible if...** - You were diagnosed with colorectal cancer (any stage) before the age of 50 - You have undergone standard diagnostic procedures and had blood drawn before any curative treatment - OR you are cancer-free and had a normal colonoscopy (as a healthy comparison group) **You may NOT be eligible if...** - You have a hereditary colorectal cancer syndrome identified by genetic testing (such as Lynch syndrome or familial adenomatous polyposis) - You have inflammatory bowel disease (Crohn's disease or ulcerative colitis) - You have not provided written informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTENCODE

A panel of microRNA, both cell-free and exosomes, whose expression level is tested from plasma samples from patients with early onset colorectal cancer and non-disease controls.


Locations(13)

City of Hope Medical Center

Duarte, California, United States

IRCCS San Raffaele

Milan, Italy

Kawasaki University

Kawasaki, Japan

Mie University

Mie, Japan

National Cancer Center Hospital

Tokyo, Japan

Tokyo Medical and Dental University

Tokyo, Japan

Yamagata University

Yamagata, Japan

Barcelona University

Barcelona, Spain

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

Barcelona, Spain

Surgery Department, Hospital del Mar, Barcelona, Spain

Barcelona, Spain

Salamanca Biomedical Research Institute

Madrid, Spain

University of Salamanca-SACYL-CSIC, Salamanca, Spain

Salamanca, Spain

University of La Laguna

San Cristóbal de La Laguna, Spain

View Full Details on ClinicalTrials.gov

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NCT06342401


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