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| Name | Class |
|---|---|
| University of Bordeaux | OTHER |
| Plateforme Oncoprot (TBMCore 3427 - US005, Bordeaux Biologie Santé) | UNKNOWN |
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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
Cholangiocarcinoma is a cancer with an increasing incidence and a poor prognosis (< 5% of all stages at 5 years). The extra-hepatic form is the most common and is rarely resectable at diagnosis (30% of cases). This is due to the late onset of symptoms, which often indicate that the disease is too advanced. It can also be explained by the diagnostic difficulties encountered with this cancer. In fact, the reference diagnostic technique is histological testing on endo-biliary cytological samples taken by biopsy and/or brushing during catheterisation of the bile ducts or by interventional radiology. The problem is that the sensitivity of this test is of the order of 50%, with an additional diagnostic uncertainty of the order of 20 to 30%, due to cellular atypia that are not sufficiently clear to confirm a cancerous pathology, although it is not possible to exclude it. This leads to diagnostic error and delay, repeated invasive examinations and sometimes major surgery for stenoses that are ultimately benign when the surgical decision has been taken without a reliable histological result. Additional diagnostic techniques are needed to diagnose a suspected extrahepatic cholangiocarcinoma stenosis, particularly at the molecular level using proteomics and, above all, proteomic profiling. Proteomic profiling enables a patient's diagnosis to be oriented towards a profile (benign or malignant) by comparing the proteins identified in formalin-fixed, paraffin-embedded tissue (cytological sample) with a set of proteins identified within a reference diagnostic signature obtained from previously analysed benign and malignant samples. Within Inserm Unit 1312 - Team 3, a proof of concept for proteomic profiling has been developed as a diagnostic tool in the face of suspected extrahepatic cholangiocarcinoma stenosis, with the development of a diagnostic signature. The aim of this project is to validate this proof of concept on a large retrospective monocentric cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suspected cholangiocarcinoma | Patient with biliary stenosis of undetermined origin who has had an endo-biliary cytological sample (biopsy and/or brushing) for suspected cholangiocarcinoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proteomic profiling | Diagnostic Test | Proteomic profiling as a diagnostic tool in the face of suspected extrahepatic cholangiocarcinoma stenosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of the proteomic profiling | Sensitivity of the proteomic profiling test combined with conventional histological diagnosis, compared with the sensitivity of the conventional histological diagnostic test alone. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of the proteomic profiling | The accuracy of the proteomic profiling associated with the conventional histological test (specificity, positive predictive value, negative predictive value) | Baseline |
| Molecular pathway of cholangiocarcinogenesis |
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Inclusion Criteria:
Exclusion Criteria:
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Patient with biliary stenosis of undetermined origin who has had an endo-biliary cytological sample (biopsy and/or brushing) for suspected cholangiocarcinoma
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Bordeaux | Pessac | France |
|
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| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| D004194 | Disease |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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Identification of the molecular pathway of cholangiocarcinogenesis using Gene Set Enrichment Analysis |
| Baseline |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |