Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06416397
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-02-01
Brief Title:
Diagnostic Approach for Cholangiocarcinoma Using Liquid Bile Biopsy
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
Diagnostic Approach for Cholangiocarcinoma Using Liquid Bile Biopsy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROTEOBILE
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 andor 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None