Evaluation of Peripheral Blood Protein Biomarkers for Colorectal Cancer Screening

Not Applicable

• Conditions: Colorectal Cancer
• Interventions: Diagnostic Test: blood sampling for screening of biomarkers

• Registration Number: NCT05520840
• Lead Sponsor: University Hospital, Rouen

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-26
• Study First Submitted QC: 2022-08-26
• Last Update Submitted: 2022-08-26
• Study First Posted: 2022-08-30
• Last Update Posted: 2022-08-30
• Study Start: 2022-09
• Primary Completion: 2023-09
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient referred for screening colonoscopy or for endoscopic resection	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Number of patient with presence of other isolated serum biomarkers selected from different candidates	Day 1

Trial Locations

Locations (3)

Caen University Hospital; 🇫🇷 Caen, France

Clinique du Cèdre; 🇫🇷 Bois-Guillaume, France

Dijon University Hospital; 🇫🇷 Dijon, France