Identification of New Diagnostic Protein Markers for Colorectal Cancer (EXOSCOL01)

October 7, 2022 updated by: CHU de Reims

Identification of New Diagnostic Protein Markers for Colorectal Cancer in Circulating Tumor Exosomes

The search for biochemical markers in patient's blood for non-invasive colorectal cancer diagnostic has not yielded satisfactory results to date. The search for blood in the stool by enzymatic techniques has certainly allowed the diminution of colorectal cancer mortality but its low sensitivity is still a disadvantage. The new immunological tests for search blood test in the stool are more sensitive and more specific but still insufficient. The originality of this project is based on the use of new technology developed in fundamental research based on the detection of circulating exosomes from tumor cells in the patient's serum. The detection of protein markers transported by tumor exosomes is original and innovative approach because it's still not considered in the literature. The use of innovative and non-invasive health technologies for the patient is an important factor in the care of patients in their health care journey. The non-invasive nature of the project could reduce the reticence of patients to participate in cancer screening.

The results expected from the study can have a direct impact on the management of patients suspected of having colon cancer and thus make it possible to optimize the earliness of their diagnosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In terms of frequency, colorectal cancer is the third most common cancer diagnosed in men and the second in women. Screening for colon and rectal cancer is based on the search for blood in the stool. The detection of occult bleeding is an indication for colonoscopy to find the origin of this bleeding. In this context, the search for biochemical markers in the blood of patients for diagnostic purposes has not yielded satisfactory results to date. Cancer cells, including colorectal cancer cells, release extracellular vesicles that contain proteins, mRNAs, DNA that can be transferred to neighboring cells but that also circulate through the blood stream and can modulate tumor progression and metastatic spread. These extracellular vesicles are of two types: exosomes (40 to 100 nm in diameter) formed by budding of endosome membranes and microvesicles (100 to 1000 nm in diameter) resulting from the budding of plasma membrane. Exosomes carry transmembrane proteins on their surface, called tetraspanins (CD9, CD63, CD81) but they also contain proteases involved in the degradation of the extracellular matrix, integrins involved in the tropism of metastases, and matrix macromolecules involved in the control of tumor invasion. The working hypothesis is that some of these exosomal proteins may be good diagnostic and / or prognostic markers for colorectal cancer. This project will aim to isolate exosomes from patient blood and to quantify previously cited proteins according to the accreditation criteria of clinical laboratory biology analyzes. For this purpose, exosomes will be isolated from sera of patients and their number, size and protein composition will be characterized. This project is an innovative and non-invasive prospective approach in the screening of protein markers for colorectal cancer diagnostic and / or prognostic.

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Reims, France, 51092
        • Chu Reims

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with and without colorectal cancer

Description

Inclusion Criteria:

  • Immunoassay for stool positive blood test or family screening
  • Patients seen in consultation for a colonoscopy
  • Patient who gave their consent for the study (signed consent form)
  • Patient affiliated to a health insurance plan

Exclusion Criteria:

  • History of other cancers (except for cervical cancer or basal cell carcinoma treated for curative purposes)
  • Patient under chemotherapy
  • Patients with a known familial mutation (APC, MSI, MYH)
  • Patients protected by law

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
colorectal cancer
Patients with and without colorectal cancer
All patients included in the study will have blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performances of markers derived from circulating tumor exosomes in the context of colorectal cancer, focusing on macromolecules
Time Frame: Day 1
Sensitivity and specificity of macromolecules
Day 1
Diagnostic performances of markers derived from circulating tumor exosomes in the context of colorectal cancer, focusing on integrins
Time Frame: Day 1
Sensitivity and specificity of integrins
Day 1
Diagnostic performances of markers derived from circulating tumor exosomes in the context of colorectal cancer, focusing on metallo proteases
Time Frame: Day 1
Sensitivity and specificity of metallo proteases
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 7, 2021

Primary Completion (ACTUAL)

July 29, 2021

Study Completion (ACTUAL)

October 7, 2022

Study Registration Dates

First Submitted

January 31, 2020

First Submitted That Met QC Criteria

May 16, 2020

First Posted (ACTUAL)

May 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 10, 2022

Last Update Submitted That Met QC Criteria

October 7, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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