Development and Validation fo an Exosome-Based and Machine Learning Powered Liquid Biopsy for the Detection of Early-Onset Colorectal Cancer

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: t
View:

• 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)

Locations
United States
California
City of Hope Medical Center
RECRUITING
Duarte
Other Locations
Italy
IRCCS San Raffaele
RECRUITING
Milan
Japan
Kawasaki University
RECRUITING
Kawasaki
Mie University
RECRUITING
Mie
National Cancer Center Hospital
RECRUITING
Tokyo
Tokyo Medical and Dental University
RECRUITING
Tokyo
Yamagata University
RECRUITING
Yamagata
Spain
Barcelona University
RECRUITING
Barcelona
Colorectal Surgery, Vall d'Hebron University Hospital, Universitat Autonoma de Barcelona UAB
RECRUITING
Barcelona
Surgery Department, Hospital del Mar, Barcelona, Spain
RECRUITING
Barcelona
Salamanca Biomedical Research Institute
RECRUITING
Madrid
University of Salamanca-SACYL-CSIC, Salamanca, Spain
RECRUITING
Salamanca
University of La Laguna
RECRUITING
San Cristóbal De La Laguna
Contact Information
Primary
Ajay Goel, PhD
AJGOEL@COH.ORG
626-218-3452
Time Frame
Start Date: 2023-04-15
Estimated Completion Date: 2025-10-15
Participants
Target number of participants: 400
Treatments
Early onset colorectal cancer (Training cohort)
Colorectal cancer diagnosed before the age of 50
Non-disease controls (Training cohort)
Individuals free from colorectal cancer, younger than 50 years of age
Early onset colorectal cancer (Validation cohort)
Colorectal cancer diagnosed before the age of 50
Non-disease controls (Validation cohort)
Individuals free from colorectal cancer, younger than 50 years of age
Related Therapeutic Areas
Sponsors
Leads: City of Hope Medical Center

This content was sourced from clinicaltrials.gov