Clinical trial NCT06416397: Diagnostic Approach for Cholangiocarcinoma Using Liquid Bile Biopsy
Official title: Diagnostic Approach for Cholangiocarcinoma Using Liquid Bile Biopsy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cholangiocarcinoma
Keywords: Cholangiocarcinoma
Diagnosis
Cancer
Proteomic profiling
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with bile duct stenosis who require ERCP or a radiological procedure for diagnostic purposes (histological samples) as part of their management

Brief summary: The main aim of the study is to develop a diagnostic proteomic profile of cholangiocarcinoma using bile samples. The primary endpoint will be the rate of concordant positive diagnoses obtained from bile samples based on proteomic profiling compared with histological reference diagnoses (concomitant cytological sampling and/or final histological sampling).

Detailed description: Cholangiocarcinoma has a poor 5-year prognosis (less than 5%) and is rarely resectable at diagnosis. Diagnosis is made by histological sampling (biopsy or endo-biliary brushing) during endoscopic retrograde catheterization of the papilla or radiologically during transparietohepatic drainage. Conventional histology techniques have a low sensitivity of around 14-60%, which leads to diagnostic delays, repeated invasive examinations and delays in therapeutic management, sometimes with progression from a resectable to an unresectable stage.

New techniques are emerging to optimize the diagnosis of cholangiocarcinoma, in particular molecular techniques. This is the case with proteomics and proteomic profiling, which consists of obtaining diagnostic information from all the proteins contained in biological samples.

Furthermore, during diagnostic procedures for cholangiocarcinoma, bile samples are taken, initially for bacteriological purposes. Proteomics has been shown to be a tool capable of identifying potential diagnostic biomarkers in bile samples. To date, proteomic profiling has never been tested on bile samples for diagnostic purposes, although its proof of concept has been established.

Obtaining a proteomic profile for the diagnosis of cholangiocarcinoma from bile samples would enable the development of an innovative tool that has not yet been described in this field. It would optimize the management of patients with cholangiocarcinoma, with the possibility of a quicker diagnosis enabling optimal management as soon as the first clinical symptoms appear, while reducing the number of examinations required to obtain a diagnosis.

Eligibility criteria: Inclusion Criteria:

* Patient 18 years and older
* Patients with bile duct stenosis who require endoscopy with retrograde papillary catheterization or a radiological procedure for diagnostic purposes (histological samples) as part of their management
* Oral consent

Exclusion Criteria:

* Pregnant woman
* Patient under legal protection

Primary outcomes:
measure: positive diagnosis of cholangiocarcinoma
timeFrame: Baseline
Secondary outcomes:
measure: Identification of diagnostic biomarkers for cholangiocarcinoma
timeFrame: Baseline
measure: differential diagnosis rates
timeFrame: Baseline
measure: positive diagnoses with the Next-Generation Sequencing technique
timeFrame: Baseline
Other outcomes:
Locations:
city: Pessac
country: France
facility: CHU Bordeaux
Study officials:
References: