Ignite Creation Date:
2024-05-06 @ 9:03 AM
Last Modification Date:
2024-10-26 @ 12:09 PM
Study NCT ID:
NCT02893085
Status:
COMPLETED
Last Update Posted:
2016-12-28
First Post:
2016-09-02
Brief Title:
Pancreatico-biliary Tumor Mutation Profiling in Bile Samples
Sponsor:
CHU de Reims
Organization:
CHU de Reims
Study Overview
Official Title:
Tumor Mutation Profiling in Bile Samples From Patients With Biliary Strictures Related to Pancreatico-biliary Cancers
Status:
COMPLETED
Status Verified Date:
2016-12
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:
ONCOBIL
Brief Summary:
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 patients 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 IDH12 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
In addition patients 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 IDH12 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None