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Evaluation of Peripheral Blood Protein Biomarkers for Colorectal Cancer Screening

Evaluation of Peripheral Blood Protein Biomarkers for Colorectal Cancer Screening

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05520840
Acronym
COLODIAG
Enrollment
350
Registered
2022-08-30
Start date
2022-12-09
Completion date
2024-09-26
Last updated
2026-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

biomarkers

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

Interventions

DIAGNOSTIC_TESTblood 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

Sponsors

University Hospital, Rouen
Lead SponsorOTHER
OncoDiag
CollaboratorUNKNOWN
University Hospital, Caen
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of patient with advanced neoplasia at colonoscopyDay 1
Number of patient with presence of best isolated serum biomarkers selected from different candidatesDay 1

Secondary

MeasureTime frame
Number of patient with presence of other isolated serum biomarkers selected from different candidatesDay 1

Countries

France

Contacts

PRINCIPAL_INVESTIGATORAdrien Grancher, MD

University Hospital, Rouen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026