Evaluation of Peripheral Blood Protein Biomarkers for Colorectal Cancer Screening

Colorectal Cancer Clinical Trial

— COLODIAG  

Official title:

Evaluation of Peripheral Blood Protein Biomarkers for Colorectal Cancer Screening

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05520840
• Other study ID #: 2022/0149/HP
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2022
• Est. completion date: September 2023

Study information

• Verified date: August 2022
• Source: University Hospital, Rouen
• Contact: Adrien Grancher, MD
• Phone: +3323288
• Email: adrien.grancher[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 350
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Clinique du Cèdre	Bois-Guillaume
France	Caen University Hospital	Caen
France	Dijon University Hospital	Dijon

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Rouen	OncoDiag, University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patient with advanced neoplasia at colonoscopy		Day 1
Primary	Number of patient with presence of best isolated serum biomarkers selected from different candidates		Day 1
Secondary	Number of patient with presence of other isolated serum biomarkers selected from different candidates		Day 1