Contents of Circulating Extracellular Vesicles: Biomarkers in Colorectal Cancer Patients

Colorectal Cancer Clinical Trial

— ExoColon  

Official title:

Contents of Circulating Extracellular Vesicles: Biomarkers in Colorectal Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04523389
• Other study ID #: COTTET 2020
• Status: Recruiting
• Start date: July 1, 2020
• Est. completion date: July 2021

Study information

• Verified date: August 2020
• Source: Centre Hospitalier Universitaire Dijon
• Contact: Vanessa COTTET
• Phone: 03.80.39.34.87
• Email: vanessa.cottet[@]u-bourgogne.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 172
• Est. completion date: July 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Chu Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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