- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04394572
Identification of New Diagnostic Protein Markers for Colorectal Cancer (EXOSCOL01)
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
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Reims, France, 51092
- Chu Reims
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
colorectal cancer
Patients with and without colorectal cancer
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All patients included in the study will have blood sample
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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
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PO19143*
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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