Diagnostic Approach for Cholangiocarcinoma Using Liquid Bile Biopsy (PROTEOBILE)

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Cholangiocarcinoma
• Intervention / Treatment: Diagnostic test: Proteomic profile

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Arthur Marichez, MD; Phone Number: +33557656005; Email: arthur.marichez@chu-bordeaux.fr

Study Locations

• France
  • Pessac, France
    • CHU Bordeaux
    • Contact: Arthur Marichez, MD; Phone Number: +33557656005; Email: arthur.marichez@chu-bordeaux.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with bile duct stenosis who require ERCP or a radiological procedure for diagnostic purposes (histological samples) as part of their management

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: February 1, 2024
• First Submitted That Met QC Criteria: May 14, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 14, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Cancer; Diagnosis; Cholangiocarcinoma; Proteomic profiling
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Cholangiocarcinoma
• Other Study ID Numbers: CHUBX 2023/69

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No