Clinical trial · Observational
Validation of the Proteomic Profiling as a Diagnostic Test for Extra-hepatic Cholangiocarcinoma
Proteomic Profiling as a Diagnostic Test for Extrahepatic Cholangiocarcinoma on Cytological Samples : Validation of a Proof-of-concept.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Proteomic profiling | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Suspected cholangiocarcinoma
- description
- Patient with biliary stenosis of undetermined origin who has had an endo-biliary cytological sample (biopsy and/or brushing) for suspected cholangiocarcinoma
- interventionNames
- Diagnostic Test: Proteomic profiling
Primary outcomes (1)
- measure
- Sensitivity of the proteomic profiling
- timeFrame
- Baseline
- description
- Sensitivity of the proteomic profiling test combined with conventional histological diagnosis, compared with the sensitivity of the conventional histological diagnostic test alone.
Secondary outcomes (2)
- measure
- Accuracy of the proteomic profiling
- timeFrame
- Baseline
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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