Contents of Circulating Extracellular Vesicles: Biomarkers in Colorectal Cancer Patients

NCT ID: NCT04523389

Last Updated: 2020-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

172 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2021-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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colorectal cancer

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

Intervention Type BIOLOGICAL

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

Gathering additional information about the patient's cancer

Intervention Type OTHER

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

Diagnostic test

Intervention Type DIAGNOSTIC_TEST

Diagnostic test

Interventions

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

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

Intervention Type BIOLOGICAL

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.

Intervention Type OTHER

Diagnostic test

Diagnostic test

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Dijon Bourgogne

Dijon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Vanessa COTTET

Role: CONTACT

03.80.39.34.87 ext. +33

Facility Contacts

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Vanessa COTTET

Role: primary

03.80.39.34.87 ext. +33

Other Identifiers

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COTTET 2020

Identifier Type: -

Identifier Source: org_study_id

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