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

Sponsor
University Hospital, Bordeaux
Study ID
NCT06780553
Status
Not Yet Recruiting

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Conditions

  • Cholangiocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Proteomic profiling — DIAGNOSTIC_TEST
    Proteomic profiling as a diagnostic tool in the face of suspected extrahepatic cholangiocarcinoma stenosis

Study Details

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

Key Dates

First listed
Jan 17, 2025
Start date
Nov 30, 2025
Status verified
Jun 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: Suspected cholangiocarcinoma
    Patient with biliary stenosis of undetermined origin who has had an endo-biliary cytological sample (biopsy and/or brushing) for suspected cholangiocarcinoma

Primary Outcome Measure

Sensitivity of the proteomic profiling [ Time Frame: Baseline ]

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