Bile proteomic test to diagnose cholangiocarcinoma
Diagnostic Approach for Cholangiocarcinoma Using Liquid Bile Biopsy
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 type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 1 site (Pessac) |
| Trial ID | NCT06416397 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Pessac
- CHU Bordeaux — Pessac, France (Recruiting)
Study contacts
- Study coordinator: Arthur Marichez, MD
- Email: arthur.marichez@chu-bordeaux.fr
- Phone: +33557656005
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.