Diagnostic Approach for Cholangiocarcinoma Using Liquid Bile Biopsy

Not yet recruiting

• Conditions: Cholangiocarcinoma

• Registration Number: NCT06416397
• Lead Sponsor: University Hospital, Bordeaux

Brief 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).

Detailed Description

Cholangiocarcinoma has a poor 5-year prognosis (less than 5%) and is rarely resectable at diagnosis. Diagnosis is made by histological sampling (biopsy or endo-biliary brushing) during endoscopic retrograde catheterization of the papilla or radiologically during transparietohepatic drainage. Conventional histology techniques have a low sensitivity of around 14-60%, which leads to diagnostic delays, repeated invasive examinations and delays in therapeutic management, sometimes with progression from a resectable to an unresectable stage.

New techniques are emerging to optimize the diagnosis of cholangiocarcinoma, in particular molecular techniques. This is the case with proteomics and proteomic profiling, which consists of obtaining diagnostic information from all the proteins contained in biological samples.

Furthermore, during diagnostic procedures for cholangiocarcinoma, bile samples are taken, initially for bacteriological purposes. Proteomics has been shown to be a tool capable of identifying potential diagnostic biomarkers in bile samples. To date, proteomic profiling has never been tested on bile samples for diagnostic purposes, although its proof of concept has been established.

Obtaining a proteomic profile for the diagnosis of cholangiocarcinoma from bile samples would enable the development of an innovative tool that has not yet been described in this field. It would optimize the management of patients with cholangiocarcinoma, with the possibility of a quicker diagnosis enabling optimal management as soon as the first clinical symptoms appear, while reducing the number of examinations required to obtain a diagnosis.

Study Timeline

• Study First Submitted: 2024-02-01
• Study First Submitted QC: 2024-05-14
• Study First Posted: 2024-05-16
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-13
• Study Start: 2025-02
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 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 Criteria

• Pregnant woman
• Patient under legal protection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
positive diagnosis of cholangiocarcinoma	Baseline	rate of positive diagnosis of cholangiocarcinoma obtained from bile samples using proteomic profile analysis compared with the rate of positive diagnosis using histological reference tools.

Secondary Outcome Measures

Name	Time	Method
Identification of diagnostic biomarkers for cholangiocarcinoma	Baseline	pecific analysis of proteomic data to identify a recurrent, malignancy-specific target protein
differential diagnosis rates	Baseline	differential diagnosis rates obtained by proteomic profiling compared with histological results
positive diagnoses with the Next-Generation Sequencing technique	Baseline	rate of positive diagnoses with the Next-Generation Sequencing technique

Trial Locations

Locations (1)

CHU Bordeaux; 🇫🇷 Pessac, France