Evaluation of Peripheral Blood Protein Biomarkers for Colorectal Cancer Screening

NCT05520840 | Completed

• 1 other identifier: 2022/0149/HP
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 3

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

Conditions

Colorectal Cancer

Keywords

biomarkers

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

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

  Day 1

Study Arms (1)

Patient referred for screening colonoscopy or for endoscopic resection

EXPERIMENTAL

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

Interventions

blood sampling for screening of biomarkers DIAGNOSTIC_TEST

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

Patient referred for screening colonoscopy or for endoscopic resection

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead
• OncoDiag: collaborator
• University Hospital, Caen: collaborator

Study Sites (3)

Clinique du Cèdre

Bois-Guillaume, France

Location

Caen University Hospital

Caen, France

Location

Dijon University Hospital

Dijon, France

Location

MeSH Terms

Conditions

Colorectal 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 Officials

• Adrien Grancher, MD

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2022
• First Posted: August 30, 2022
• Study Start: December 9, 2022
• Primary Completion: September 26, 2024
• Study Completion: September 26, 2024
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)