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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 50 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "This study involves the development and validation of a liquid biopsy, assessing circulating cell-free and exosomal microRNAs (cf-miRNA and exo-miRNA, respectively) for indirect sampling of tumor tissue in the bloodstream."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a blood test to find cancer of the colon or rectum in people diagnosed before age 50. The test looks at tiny molecules called microRNA. The study includes people with this cancer and people shown to be cancer-free by a colonoscopy.

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)

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • For the cancer group: colon or rectal cancer at any stage (I–IV), diagnosed before age 50.
  • For the cancer group: had standard tests to diagnose the cancer and check how far it had spread, following local guidelines.
  • For the cancer group: had at least one sample collected before any treatment meant to cure the cancer.
  • For the cancer-free group: a colonoscopy showed no cancer when joining the study. This test uses a camera to look inside the colon and rectum.

Who can't join

  • An inherited condition linked to colon or rectal cancer, found through genetic testing.
  • Inflammatory bowel disease, which causes long-term swelling in the digestive tract.
  • No written consent to join the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

CA