Pancreatico-biliary Tumor Mutation Profiling In Bile Samples

Study Overview

Pancreatico-biliary Tumor Mutation Profiling in Bile Samples

The differential diagnosis between benign and malignant bile duct strictures is a difficult and demanding task for clinicians. Clinical, biochemical, and radiological characteristics of malignant biliary strictures are non-specific and tissue diagnosis is difficult to obtain preoperatively. For this reason, there is a need for the development of new diagnostic modalities. Of particular interest is the quest of tumor markers secreted or shed in bile by tumor cells developing in the biliary tract. In addition, patient's tumor molecular profile is the basis for selecting personalized therapy. Cholangiocarcinomas are characterized by a large genetic heterogeneity. The most frequent mutations are TP53, KRAS, BRAF, EGFR, MET, NRAS, PIK3CA, ERBB2, SMAD4, FBXW7, ARID1A, PBRM1, BAP1 et IDH1/2. In the case of pancreatic cancers, the most frequent are KRAS mutation detected in 90 % of the patients and CDKN2A, SMAD4, TGFBR1, TGFBR2, ATM, BRCA2, MLL2, MLL3, KDM6A, ARID1A, ARID1B, SMARC1, GNAS and RNF43 mutations. It is well established that KRAS and P53 mutations can be detected in bile samples from patients with biliary strictures related to cholangiocarcinoma and cancer of the head of the pancreas. The main objective is to determine if bile sample analysis from patients with malignant biliary stricture may allow to identify tumor mutation profile and determine tumor genotype. A secondary objective is to evaluate the diagnostic value of Vascular Endothelial Growth Factor (VEGF) and metallo-proteinases (MMPs) levels in bile samples. Tumor genotyping will be performed in bile samples (supernatant and cell pellet) and tumor tissues in a series of 10 patients surgically treated for malignant biliary stricture related to cholangiocarcinoma or cancer of the head of the pancreas. The biochemical markers, VEGF and MMPs, will be assessed in bile samples obtained during endoscopic retrograde cholangiopancreatography in 50 patients with malignant biliary stricture and 50 patients treated for benign biliary diseases.

N/A

Cholangiocarcinoma, Cancer of the Head of the Pancreas

BIOLOGICAL: bile sample analysis
BIOLOGICAL: biochemical markers, VEGF and MMPs, in bile samples

PA15117

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2016-09-02	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2016-12-27
First Submitted that Met QC Criteria 2016-09-02	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2016-12-28
First Posted (ESTIMATED) 2016-09-08	Results First Posted N/A	Last Verified 2016-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: patients with malignant biliary stricture	BIOLOGICAL: bile sample analysis tumor mutation profile tumor genotype BIOLOGICAL: biochemical markers, VEGF and MMPs, in bile samples
: patients with benign biliary diseases	BIOLOGICAL: biochemical markers, VEGF and MMPs, in bile samples

Participant Group/Arm

Intervention/Treatment

: patients with malignant biliary stricture

BIOLOGICAL: bile sample analysis

tumor mutation profile tumor genotype

BIOLOGICAL: biochemical markers, VEGF and MMPs, in bile samples

: patients with benign biliary diseases

BIOLOGICAL: biochemical markers, VEGF and MMPs, in bile samples

Primary Outcome Measures	Measure Description	Time Frame
Tumor genotyping		Day 0

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

patients surgically treated for malignant biliary stricture related to cholangiocarcinoma or cancer of the head of the pancreas.
diagnosis of cholangiocarcinoma or cancer of the head of the pancreas confirmed by histopathological analysis of the resected specimen
adult patients

patients with benign biliary diseases or malignant biliary stricture (cholangiocarcinoma or cancer of the head of the pancreas.
indication of endoscopic retrograde cholangiopancreatography for diagnostic and therapeutic purposes
adult patients Exclusion criteria
patient who did not accept the storage of bile and tissue in the tissue Bank of Reims university hospital

Collaborators and Investigators

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Clinical Trial Record