Genomic Analysis of Peritoneal Mesothelioma by CGH Arrays

Peritoneal Mesothelioma Clinical Trial

Official title:

Genomic Analysis of Peritoneal Mesothelioma by CGH Arrays

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02834234
• Other study ID #: D50828
• Status: Completed
• Phase: N/A
• First received: April 27, 2016
• Last updated: July 25, 2016
• Start date: May 2013
• Est. completion date: January 2016

Study information

• Verified date: July 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Mesothelioma
• Peritoneal Mesothelioma

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BAP1 mutations	CGH Array	Day 0	No