Contents of Circulating Extracellular Vesicles: Biomarkers in Colorectal Cancer Patients

NCT04523389 | Terminated

• 1 other identifier: COTTET 2020
• Study Type: observational
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

colorectal cancer

Biological: analysis (protein, lipid, RNA ...) of circulating exosomes, size and number; Other: Gathering additional information about the patient's cancer; Diagnostic Test: Diagnostic test

Interventions

Diagnostic test DIAGNOSTIC_TEST

Diagnostic test

colorectal cancer

analysis (protein, lipid, RNA ...) of circulating exosomes, size and number BIOLOGICAL

use of blood samples stored at the Ferdinand Cabanne Biological Resource Centre

colorectal cancer

Gathering additional information about the patient's cancer OTHER

Gathering additional information about the patient's cancer, its treatment and its sequelae from the patient's medical record.

colorectal cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Person included in the AGARIC study
• Available blood sample in the AGARIC biobank at the Biological Resource Centre (Dijon)

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Non-codant

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Proteins; Lipids; RNA; Diagnostic Tests, Routine

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins; Nucleic Acids; Nucleic Acids, Nucleotides, and Nucleosides; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 21, 2020
• Study Start: July 1, 2020
• Primary Completion: March 18, 2026
• Study Completion: March 18, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

FR (1)