Diagnostic Approach for Cholangiocarcinoma Using Liquid Bile Biopsy

NCT06416397 | Recruiting

• 1 other identifier: CHUBX 2023/69
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

Cholangiocarcinoma

Keywords

Cholangiocarcinoma; Diagnosis; Cancer; Proteomic profiling

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Identification of diagnostic biomarkers for cholangiocarcinoma

  Baseline

• differential diagnosis rates

  Baseline

• positive diagnoses with the Next-Generation Sequencing technique

  Baseline

Interventions

Proteomic profile DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Pregnant woman
• Patient under legal protection

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU Bordeaux

Pessac, France

RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma; Disease; Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Arthur Marichez, MD

CONTACT

+33557656005; arthur.marichez@chu-bordeaux.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: May 16, 2024
• Study Start: April 8, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)