Clinical trial Recruiting at 1 site Observational Ages 18 and up

Bile proteomic test to diagnose cholangiocarcinoma

Official title: Diagnostic Approach for Cholangiocarcinoma Using Liquid Bile Biopsy

Run by University Hospital, Bordeaux · NCT06416397 · Data updated 2026-11-12

We will try a proteomic analysis of bile to see if it can detect cholangiocarcinoma in adults who are having diagnostic bile sampling.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment200 (estimated)
SponsorUniversity Hospital, Bordeaux
Academic / other
Locations1 site (Pessac)
StatusRecruiting
StartedApril 8, 2025
Main results expectedFebruary 2026
Study endsFebruary 2026
Registry record updatedDecember 16, 2025
Trial IDNCT06416397 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18 or older with biliary strictures who are scheduled for diagnostic ERCP or radiologic biliary drainage and who can give oral consent are the intended participants.

Probably not a fit

Pregnant people, individuals under legal protection, or patients who will not have bile sampling as part of their care are unlikely to benefit from this approach.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational project aims to create a diagnostic proteomic profile for cholangiocarcinoma using bile collected during routine endoscopic or radiologic biliary procedures. Bile obtained during ERCP or percutaneous biliary drainage will undergo proteomic profiling and the results will be compared with concurrent cytology/biopsy or final histological diagnoses. The primary endpoint is the rate of concordant positive diagnoses between bile proteomics and the histological reference standard. The approach builds on prior proteomic biomarker work in bile and other biofluids to develop a minimally invasive diagnostic tool.

Why it matters

Potential benefit: If successful, this could provide quicker and more accurate diagnosis from bile samples, reducing repeat invasive procedures and allowing earlier treatment decisions.

How similar studies have gone: Proteomic methods have identified potential biomarkers in bile and other fluids, but using proteomic profiling of bile specifically for cholangiocarcinoma diagnosis has not yet been established in clinical practice.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • CHU Bordeaux
    Pessac, France
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.