Contents of Circulating Extracellular Vesicles: Biomarkers in Colorectal Cancer Patients (ExoColon)

Most cancer-related deaths are caused by distant metastases, which are tumour cells that have escaped from a primary tumour and passed into the bloodstream to colonize a new organ. In this context, communication between tumour and stromal cells is essential. Indeed, tumor cells interact with cells in the tumor microenvironment and are able to modify them to their advantage. Both extracellular vesicles (EVs) and exosomes are heterogeneous populations of small vesicles present in the tumor microenvironment and in body fluids that have recently emerged as powerful mediators involved in this communication and their transport in fluids. Tumor cells release large quantities of exosomes containing tumor markers, which can then spread to distant locations.

The exosomes are of endosomal origin. They are composed of proteins, lipids, RNA and DNA, and they circulate in the bloodstream. They can be internalized by specific distant cells and thus deliver a functional message. It has recently been shown that tumor exosomes containing pro-metastatic factors form pre-metastatic niches, before the tumor cells actually arrive, while determining the metastatic organotropism of tumors. These properties are now opening up new avenues of research in tumor biomarkers. In recent years, several studies have highlighted different markers contained specifically in exosomes derived from cancer cells. Consequently, exosomes are considered as potential reservoirs of tumor biomarkers that could be clinically useful for the non-invasive diagnosis of cancer, with the advantage of being performed by liquid biopsy. The study of microRNA (miRNA) is of particular interest. Indeed, miRNAs are small non-coding RNAs (between 21 and 25 nucleotides) involved in the regulation of gene expression and which are frequently deregulated in cancer. Several studies underline that the variation of free miRNAs in the blood is correlated with the progression of the disease, particularly in colon cancer. However, the stability of free miRNAs is controversial. Therefore, exosomes represent a very advantageous means of transporting miRNAs in the blood, as they are able to protect miRNAs from degradation by RNAase.

The hypothesis of the project is that circulating exosomes derived from tumours contain markers including specific miRNAs that could be used as biomarkers of early prognosis (survival and progression), easily measured in blood samples from patients with colon cancer. But other molecules contained in exosomes could also be of interest.

Study Overview

• Status: Terminated
• Conditions: Colorectal Cancer
• Intervention / Treatment: Biological: analysis (protein, lipid, RNA ...) of circulating exosomes, size and number; Other: Gathering additional information about the patient's cancer; Diagnostic test: Diagnostic test

• Study Type: Observational
• Enrollment (Actual): 172

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21000
    • CHU Dijon Bourgogne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients diagnosed with colorectal cancer and included in the AGARIC study between 2008 and 2012

Description

Inclusion Criteria:

• Person included in the AGARIC study
• Person who provided consent or non-opposition to inclusion in the study
• Available blood sample in the AGARIC biobank at the Biological Resource Centre (Dijon)

Exclusion Criteria:

NA

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

colorectal cancer

Biological: analysis (protein, lipid, RNA ...) of circulating exosomes, size and number; use of blood samples stored at the Ferdinand Cabanne Biological Resource Centre; Other: Gathering additional information about the patient's cancer; Gathering additional information about the patient's cancer, its treatment and its sequelae from the patient's medical record.; Diagnostic test: Diagnostic test; Diagnostic test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prognostic role of exosomes and their contents on the survival of colorectal cancer patients	main criterion of judgment: occurrence of death until 30/06/2020	throughout the study a average of 1 year
Association between the number and size of exosomes and their content on cancer stage and progression	cancer stage to diagnosis; progression of the disease assessed according to the RECIST criteria and defined as (i) local-regional relapse, (ii) distant relapse, (iii) metastasis, (iv) development of another cancer until 30/06/2020.	throughout the study a average of 1 year

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): March 18, 2026
• Study Completion (Actual): March 18, 2026

Study Registration Dates

• First Submitted: August 19, 2020
• First Submitted That Met QC Criteria: August 20, 2020
• First Posted (Actual): August 21, 2020

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms; Amino Acids, Peptides, and Proteins; Diagnostic Techniques and Procedures; Diagnosis; Nucleic Acids; Nucleic Acids, Nucleotides, and Nucleosides; RNA; Proteins; Diagnostic Tests, Routine; Lipids
• Other Study ID Numbers: COTTET 2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No