Pancreatico-biliary Tumor Mutation Profiling in Bile Samples

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StatusZavršeno

Sponzori

CHU de Reims

KLINIČKIM ISPITIVANJIMA: NCT02893085

BioSeek: nct02893085

Ključne riječi

Sažetak

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.

Datumi

Posljednja provjera:	11/30/2016
Prvo podneseno:	09/01/2016
Predviđena prijava predata:	09/01/2016
Prvo objavljeno:	09/07/2016
Zadnje ažuriranje poslato:	12/26/2016
Posljednje ažuriranje objavljeno:	12/27/2016
Stvarni datum početka studija:	08/31/2015
Procijenjeni datum primarnog završetka:	09/30/2016
Predviđeni datum završetka studije:	09/30/2016

Stanje ili bolest

Cholangiocarcinoma, Cancer of the Head of the Pancreas

Intervencija / liječenje

Biological: patients with malignant biliary stricture

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

Faza

Grupe ruku

Arm	Intervencija / liječenje
patients with malignant biliary stricture	Biological: patients with malignant biliary stricture tumor mutation profile tumor genotype
patients with benign biliary diseases

Kriteriji prihvatljivosti

Uzrast podoban za studiranje	18 Years To 18 Years
Polovi podobni za studiranje	All
Metoda uzorkovanja	Non-Probability Sample
Prihvaća zdrave volontere	Da
Kriterijumi	1. Tumor genotyping in bile samples: Inclusion criteria : - 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 Exclusion criteria : - patient who did not accept the storage of bile and tissue in the tissue Bank of Reims university hospital 2. Measurement of biochemical markers, VEGF and MMPs in bile samples obtained during endoscopic retrograde cholangiopancreatography in 50 patients with malignant biliary stricture and 50 patients treated for benign biliary diseases. Inclusion criteria: - 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

Ishod

Primarne mjere ishoda

1. Tumor genotyping [Day 0]