Cholangiocarcinoma, Cancer of the Head of the Pancreas Clinical Trial
— ONCOBILOfficial title:
Tumor Mutation Profiling in Bile Samples From Patients With Biliary Strictures Related to Pancreatico-biliary Cancers
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.
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | October 2016 |
| Est. primary completion date | October 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Case Control, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| France | Chu Reims | France | Reims |
| Lead Sponsor | Collaborator |
|---|---|
| CHU de Reims |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Tumor genotyping | Day 0 | No |