Not Yet RecruitingNot Applicable

Validation of the Proteomic Profiling as a Diagnostic Test for Extra-hepatic Cholangiocarcinoma

France60 participantsStarted 2025-11

Plain-language summary

The study aims to valide a proof of a concept of the proteomic profiling as a diagnostic tool for bile duct stenosis suspicious of cholangiocarcinoma. The main objective is to evaluate the addition of proteomic profiling to the conventional histological diagnosis of endo-biliary cytological sampling of biliary stenosis, compared with cytological sampling alone. With the addition of proteomic profiling to the conventional histological diagnostic technique, an overall diagnostic sensitivity of 80% is expected

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Age ≥ 18 years * Patient with biliary stenosis of undetermined origin who has had an endo-biliary cytological sample (biopsy and/or brushing) for suspected cholangiocarcinoma, fixed in formalin and included in paraffin with at least 1 year of follow-up. * No objection to re-use of data Exclusion Criteria: * Absence of cellular material usable in proteomics on residual histological block * Presence of pancreatic adenocarcinoma demonstrated on cytological sampling, definitive histology after surgical resection and/or clinical-morphological follow-up of at least one year. * Patient under legal protection

What they're measuring

Sensitivity of the proteomic profiling

Timeframe: Baseline

Trial details

NCT IDNCT06780553

SponsorUniversity Hospital, Bordeaux

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-03

View on ClinicalTrials.gov More Cholangiocarcinoma trials