Clinical trial NCT06780553: Validation of the Proteomic Profiling as a Diagnostic Test for Extra-hepatic Cholangiocarcinoma
Official title: Proteomic Profiling as a Diagnostic Test for Extrahepatic Cholangiocarcinoma on Cytological Samples : Validation of a Proof-of-concept.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cholangiocarcinoma
Keywords: cholangiocarcinoma
biopsy
diagnosis
proteomic profiling
proteomic
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: University of Bordeaux
name: Plateforme Oncoprot (TBMCore 3427 - US005, Bordeaux Biologie Santé)
First posted: 2025-01-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with biliary stenosis of undetermined origin who has had an endo-biliary cytological sample (biopsy and/or brushing) for suspected cholangiocarcinoma

Brief 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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity of the proteomic profiling
timeFrame: Baseline
Secondary outcomes:
measure: Accuracy of the proteomic profiling
timeFrame: Baseline
measure: Molecular pathway of cholangiocarcinogenesis
timeFrame: Baseline
Other outcomes:
Locations:
city: Pessac
country: France
facility: CHU Bordeaux
Study officials:
References: