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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02893085
Other study ID # PA15117
Secondary ID
Status Completed
Phase N/A
First received September 2, 2016
Last updated December 27, 2016
Start date September 2015
Est. completion date October 2016

Study information

Verified date December 2016
Source CHU de Reims
Contact n/a
Is FDA regulated No
Health authority France: The Commission nationale de l’informatique et des libertés
Study type Observational

Clinical Trial 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, 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.


Recruitment information / eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Biological:
bile sample analysis
tumor mutation profile tumor genotype
biochemical markers, VEGF and MMPs, in bile samples


Locations

Country Name City State
France Chu Reims France Reims

Sponsors (1)

Lead Sponsor Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tumor genotyping Day 0 No