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

Inclusion Criteria3

  • 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 Criteria3

  • Hereditary colorectal cancer syndromes (identified through genetic testing)
  • Inflammatory bowel diseases
  • Lack of written informed consent

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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