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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04523389
Recruitment Status : Recruiting
First Posted : August 21, 2020
Last Update Posted : August 21, 2020
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

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.

Condition or disease Intervention/treatment
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

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Study Type : Observational
Estimated Enrollment : 172 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Contents of Circulating Extracellular Vesicles: Biomarkers in Colorectal Cancer Patients
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : July 2021

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

Primary Outcome Measures :
  1. Prognostic role of exosomes and their contents on the survival of colorectal cancer patients [ Time Frame: throughout the study a average of 1 year ]
    main criterion of judgment: occurrence of death until 30/06/2020

  2. Association between the number and size of exosomes and their content on cancer stage and progression [ Time Frame: throughout the study a average of 1 year ]
    • 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.

Biospecimen Retention:   Samples With DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04523389

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Contact: Vanessa COTTET ext +33

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Chu Dijon Bourgogne Recruiting
Dijon, France, 21000
Contact: Vanessa COTTET ext +33   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
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Responsible Party: Centre Hospitalier Universitaire Dijon Identifier: NCT04523389    
Other Study ID Numbers: COTTET 2020
First Posted: August 21, 2020    Key Record Dates
Last Update Posted: August 21, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases