Diagnostic Approach for Cholangiocarcinoma Using Liquid Bile Biopsy

Cholangiocarcinoma Clinical Trial

— PROTEOBILE  

Official title:

Diagnostic Approach for Cholangiocarcinoma Using Liquid Bile Biopsy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06416397
• Other study ID #: CHUBX 2023/69
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: February 2026

Study information

• Verified date: May 2024
• Source: University Hospital, Bordeaux
• Contact: Arthur Marichez, MD
• Phone: +33557656005
• Email: arthur.marichez[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: February 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cholangiocarcinoma

Intervention

Diagnostic Test:
• Proteomic 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

Country	Name	City	State
France	CHU Bordeaux	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	positive diagnosis of cholangiocarcinoma	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.	Baseline
Secondary	Identification of diagnostic biomarkers for cholangiocarcinoma	pecific analysis of proteomic data to identify a recurrent, malignancy-specific target protein	Baseline
Secondary	differential diagnosis rates	differential diagnosis rates obtained by proteomic profiling compared with histological results	Baseline
Secondary	positive diagnoses with the Next-Generation Sequencing technique	rate of positive diagnoses with the Next-Generation Sequencing technique	Baseline