Genomic Analysis of Peritoneal Mesothelioma by CGH Arrays

NCT02834234 | Completed

• 1 other identifier: D50828
• Study Type: observational
• Target: 33
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Peritoneal Mesothelioma

Keywords

mesothelioma; peritoneum; genomic; CGH arrays

Outcome Measures

Primary Outcomes (1)

• BAP1 mutations

  CGH Array

  Day 0

Study Arms (1)

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

Interventions

comparative genomic analysis GENETIC

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

Peritoneal mesothelioma specimens

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with diagnosis of peritoneal mesothelioma

You may qualify if:

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

You may not qualify if:

• absence of peritoneal mesothelioma
• absence of frozen samples

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Biospecimen

Retention: SAMPLES WITH DNA

mesothelioma tumor specimen and normal tissue specimen

MeSH Terms

Conditions

Mesothelioma

Interventions

Comparative Genomic Hybridization

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial

Intervention Hierarchy (Ancestors)

Cytogenetic Analysis; Genetic Techniques; Investigative Techniques; Molecular Diagnostic Techniques; Nucleic Acid Hybridization

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2016
• First Posted: July 15, 2016
• Study Start: May 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: July 26, 2016

Record last verified: 2016-07