Contents of Circulating Extracellular Vesicles: Biomarkers in Colorectal Cancer Patients (ExoColon)
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|ClinicalTrials.gov Identifier: NCT04523389|
Recruitment Status : Recruiting
First Posted : August 21, 2020
Last Update Posted : August 21, 2020
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|
|Study Type :||Observational|
|Estimated Enrollment :||172 participants|
|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|
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
- 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
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT04523389
|Contact: Vanessa COTTET||03.80.39.34.87 ext +firstname.lastname@example.org|
|Chu Dijon Bourgogne||Recruiting|
|Dijon, France, 21000|
|Contact: Vanessa COTTET 03.80.39.34.87 ext +33 email@example.com|