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Evaluation of Peripheral Blood Protein Biomarkers for Colorectal Cancer Screening (COLODIAG)

Primary Purpose

Colorectal Cancer

Status

Not yet recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

blood sampling for screening of biomarkers

About this trial

This is an interventional diagnostic trial for Colorectal Cancer focused on measuring biomarkers

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient aged 50 years or older referred for screening colonoscopy after a positive FIT test or for endoscopic resection of a previously identified suspicious colorectal lesion

Exclusion Criteria:

Very high risk of colorectal cancer: Lynch syndrome, Familial adenomatous polyposis, Peutz-Jeghers syndrome, Familial polyposis associated with a MutYH gene defect
Other solid cancers or haematological malignancies that are progressive and/or undergoing treatment (apart from basal cell skin carcinoma)
Contraindication to total colonoscopy

Sites / Locations

Clinique du Cèdre
Caen University Hospital
Dijon University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient referred for screening colonoscopy or for endoscopic resection

Arm Description

Patient aged 50 years or older referred for screening colonoscopy after a positive fecal immunochemical test or for endoscopic resection of a previously identified suspicious colorectal lesion will have a blood sampling for biomarkers detection

Outcomes

Primary Outcome Measures

Number of patient with advanced neoplasia at colonoscopy

Number of patient with presence of best isolated serum biomarkers selected from different candidates

Secondary Outcome Measures

Number of patient with presence of other isolated serum biomarkers selected from different candidates

Full Information

NCT ID

NCT05520840

First Posted

August 26, 2022

Last Updated

August 26, 2022

Sponsor

University Hospital, Rouen

Collaborators

OncoDiag, University Hospital, Caen

1. Study Identification

Unique Protocol Identification Number

NCT05520840

Brief Title

Evaluation of Peripheral Blood Protein Biomarkers for Colorectal Cancer Screening

Acronym

COLODIAG

Official Title

Evaluation of Peripheral Blood Protein Biomarkers for Colorectal Cancer Screening

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 2022 (Anticipated)

Primary Completion Date

September 2023 (Anticipated)

Study Completion Date

September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Rouen

Collaborators

OncoDiag, University Hospital, Caen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of the study is to validate the value of value of peripheral blood protein biomarkers in colorectal cancer screening, and to identify new ones

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

Keywords

biomarkers

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patient referred for screening colonoscopy or for endoscopic resection

Arm Type

Experimental

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

blood sampling for screening of biomarkers

Intervention Description

Primary Outcome Measure Information:

Title

Number of patient with advanced neoplasia at colonoscopy

Time Frame

Day 1

Title

Number of patient with presence of best isolated serum biomarkers selected from different candidates

Time Frame

Day 1

Secondary Outcome Measure Information:

Title

Number of patient with presence of other isolated serum biomarkers selected from different candidates

Time Frame

Day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient aged 50 years or older referred for screening colonoscopy after a positive FIT test or for endoscopic resection of a previously identified suspicious colorectal lesion Exclusion Criteria: Very high risk of colorectal cancer: Lynch syndrome, Familial adenomatous polyposis, Peutz-Jeghers syndrome, Familial polyposis associated with a MutYH gene defect Other solid cancers or haematological malignancies that are progressive and/or undergoing treatment (apart from basal cell skin carcinoma) Contraindication to total colonoscopy

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Adrien Grancher, MD

Phone

+3323288

Ext

8610

adrien.grancher@chu-rouen.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Julien BLOT

Phone

+3323288

Ext

8265

julien.blot@chu-rouen.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adrien Grancher, MD

Organizational Affiliation

Rouen University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinique du Cèdre

City

Bois-Guillaume

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aude DI FIORE

Facility Name

Caen University Hospital

City

Caen

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Karine BOUHIER, MD

Facility Name

Dijon University Hospital

City

Dijon

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sylvain MANFREDI, Pr

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Evaluation of Peripheral Blood Protein Biomarkers for Colorectal Cancer Screening

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