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Pancreatico-biliary Tumor Mutation Profiling in Bile Samples

NCT ID: NCT02893085

Last Updated: 2016-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cholangiocarcinoma, Cancer of the Head of the Pancreas

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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patients with malignant biliary stricture

bile sample analysis

Intervention Type BIOLOGICAL

tumor mutation profile tumor genotype

biochemical markers, VEGF and MMPs, in bile samples

Intervention Type BIOLOGICAL

patients with benign biliary diseases

biochemical markers, VEGF and MMPs, in bile samples

Intervention Type BIOLOGICAL

Interventions

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bile sample analysis

tumor mutation profile tumor genotype

Intervention Type BIOLOGICAL

biochemical markers, VEGF and MMPs, in bile samples

Intervention Type BIOLOGICAL

Eligibility Criteria

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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


* 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

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.

* patient who did not accept the storage of bile and tissue in the tissue Bank of Reims university hospital
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CHU de Reims

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Reims

France, Reims, France

Site Status

Countries

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France

Other Identifiers

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PA15117

Identifier Type: -

Identifier Source: org_study_id