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

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

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Diagnostic test: blood sampling for screening of biomarkers

• Study Type: Interventional
• Enrollment (Actual): 350
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bois-Guillaume, France
    • Clinique du Cèdre
  • Caen, France
    • Caen University Hospital
  • Dijon, France
    • Dijon University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient referred for screening colonoscopy or for endoscopic resection; 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	Diagnostic test: blood sampling for screening of biomarkers; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patient with advanced neoplasia at colonoscopy	Day 1
Number of patient with presence of best isolated serum biomarkers selected from different candidates	Day 1

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of patient with presence of other isolated serum biomarkers selected from different candidates	Day 1

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Collaborators: University Hospital, Caen; OncoDiag
• Investigators: Principal Investigator: Adrien Grancher, MD, University Hospital, Rouen

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2022
• Primary Completion (Actual): September 26, 2024
• Study Completion (Actual): September 26, 2024

Study Registration Dates

• First Submitted: August 26, 2022
• First Submitted That Met QC Criteria: August 26, 2022
• First Posted (Actual): August 30, 2022

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: biomarkers
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: 2022/0149/HP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No