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Genomic Analysis of Peritoneal Mesothelioma by CGH Arrays

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02834234
Recruitment Status : Completed
First Posted : July 15, 2016
Last Update Posted : July 26, 2016
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:
Peritoneal mesothelioma is a rare disease representing one third of all mesothelioma and nothing is known about molecular characteristics of this disease. As main cancers, genetic heterogeneity is probable. This genomic profiling associates Comparative Genomic Hybridization (CGH) array, BAP1 sequencing and gene expression in order to discover a biomarker that could be used in the treatment of this rare disease. Corresponding histopathological and immunohistochemical report as all clinical data are available. All data with be merged to underline a few genes of interest on which we will focus our next investigations. Depending of our preliminary results, BAP1 mutations are expected, as it was also described in pleural mesothelioma. Mutations in oncogenic drivers that could be targeted by specific therapy will be on particular interest in management of this rare disease with bad prognosis.

Condition or disease Intervention/treatment
Peritoneal Mesothelioma Genetic: comparative genomic analysis

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Study Type : Observational
Actual Enrollment : 33 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Genomic Analysis of Peritoneal Mesothelioma by CGH Arrays
Study Start Date : May 2013
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

Group/Cohort Intervention/treatment
Peritoneal mesothelioma specimens

The group harbors only patients who received the diagnosis of peritoneal mesothelioma after surgery. All patients are included in this group.

The CGH arrays will be realized on frozen samples (for the comparative genomic analysis).

Genetic: comparative genomic analysis
DNA and RNA extraction will be performed in Lyon University hospital (genomic platform) using commercially available kit. Percentage of tumors cells will be controlled by stained section before extraction. The CGH arrays will be realized on frozen samples in Lille (genomic platform). Pangenomic Agilent array will be used. Micro-array include 180000 probes. Analysis will be performed in Lille (genomic platform / department of BioInformatics) with Marie Brevet. Data will be processed from the log2 transformed data into normalization with the WACA method. Then copy number variation will then be identified with Circular Binary Segmentation. Copy number variations will be called as gain or deletion according to the log2 ratio distribution and the percent of tumoral cells. Using matched tumoral and normal DNA will eliminate Copy Number Polymorphisms. We will construct non supervised hierarchical analyses to study the classification of peritoneal mesothelioma based on copy number variation

Primary Outcome Measures :
  1. BAP1 mutations [ Time Frame: Day 0 ]
    CGH Array

Biospecimen Retention:   Samples With DNA
mesothelioma tumor specimen and normal tissue specimen

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with diagnosis of peritoneal mesothelioma

Inclusion Criteria:

  • surgical biopsy od the peritoneal tumor with frozen samples
  • age > 18 years old

Exclusion Criteria:

  • absence of peritoneal mesothelioma
  • absence of frozen samples
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Responsible Party: Hospices Civils de Lyon Identifier: NCT02834234    
Other Study ID Numbers: D50828
First Posted: July 15, 2016    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016
Keywords provided by Hospices Civils de Lyon:
CGH arrays
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial