RecruitingNCT06416397

Diagnostic Approach for Cholangiocarcinoma Using Liquid Bile Biopsy


Sponsor

University Hospital, Bordeaux

Enrollment

200 participants

Start Date

Apr 8, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

The main aim of the study is to develop a diagnostic proteomic profile of cholangiocarcinoma using bile samples. The primary endpoint will be the rate of concordant positive diagnoses obtained from bile samples based on proteomic profiling compared with histological reference diagnoses (concomitant cytological sampling and/or final histological sampling).


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Patient 18 years and older
  • Patients with bile duct stenosis who require endoscopy with retrograde papillary catheterization or a radiological procedure for diagnostic purposes (histological samples) as part of their management
  • Oral consent

Exclusion Criteria2

  • Pregnant woman
  • Patient under legal protection

Interventions

DIAGNOSTIC_TESTProteomic profile

Proteomic analysis of bile samples will be performed every 5 bile samples. Bile samples will be taken during endoscopy with retrograde papillary catheterization or radiological procedures in selected patients. In clinical practice, bile samples are taken for bacteriological purposes. An average of 10 mL is taken. Five mL are required for bacteriological analysis. The remaining millilitres, which are usually discarded, will be kept for storage and to form the bile bank at the Biological Resources Centre before to be analyzed in proteomics.


Locations(1)

CHU Bordeaux

Pessac, France

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NCT06416397


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