Identification of New Diagnostic Protein Markers for Colorectal Cancer

NCT04394572 | Completed

• 1 other identifier: PO19143*
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer

Keywords

exosome ; colon cancer; integrin; matrix metalloproteinases

Outcome Measures

Primary Outcomes (3)

• Diagnostic performances of markers derived from circulating tumor exosomes in the context of colorectal cancer, focusing on macromolecules

  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

  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

  Sensitivity and specificity of metallo proteases

  Day 1

Study Arms (1)

colorectal cancer

Patients with and without colorectal cancer

Biological: Blood sample

Interventions

Blood sample BIOLOGICAL

All patients included in the study will have blood sample

colorectal cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with and without colorectal cancer

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu Reims

Reims, 51092, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: May 19, 2020
• Study Start: January 7, 2021
• Primary Completion: July 29, 2021
• Study Completion: October 7, 2022
• Last Updated: October 10, 2022

Record last verified: 2022-10

Locations

FR (1)