Prospectively Collected Pleural Biopsies for Validation of Malignant Pleural Mesothelioma Prognostic Biomarkers

Study Overview
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Brief Summary
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This research study is evaluating a new method for determining stage and prognosis of individuals with malignant pleural mesothelioma.

Detailed Description
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The purpose of this research study is to test a new method for determining the stage and prognosis of patients with malignant pleural mesothelioma. Currently, it is not possible to accurately determine cancer stage prior to surgery or another treatment. This new method may allow doctors to better classify cancer stage and give a better estimate for prognosis prior to surgery or another treatment. In this research study, the investigators would like to use biopsied tissue to study certain characteristics that will help test the new method for determining cancer stage and estimating prognosis. In this research study, the investigators are... Obtaining pleural specimens at the time of routine diagnostic biopsy during the participant's standard treatment. Storing your biopsied tissue Studying the tissue to determine if the new method of staging and prognosis is accurate and valid

Official Title
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Prospectively Collected Pleural Biopsies for Validation of Malignant Pleural Mesothelioma Prognostic Biomarkers

Conditions
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Mesothelioma

Intervention / Treatment
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* Other: MPT Test
* Other: CLDN15/VIM Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All adult patients with a diagnosis of malignant pleural mesothelioma undergoing diagnostic pleural biopsy pleuroscopy and/or VATS resections Participants must be 18 years of age or older. Exclusion Criteria: -Any patient who is found to be unsuitable for surgery, treatment diagnosis,

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MRiS<br>The specimens to be collected will include at least five pleural biopsy samples MPT test and the CLDN15/VIM test will be performed | Other: MPT Test<br>* molecular expression tests at the RNA level using approximately 7 or more genes with RTPCR, nanostring or similar platforms<br>Other: CLDN15/VIM Test<br>* molecular expression tests at the RNA level using approximately 7 or more genes with RTPCR, nanostring or similar platforms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-treatment Prognostic Algorithm Validation | The primary objective is to utilize a novel prognostic algorithm to predict the outcome of MPM patients. This algorithm includes 4 different tests: molecular, radiological, and blood based. It will be performed on 240 prospectively-collected samples. A score of 0-4 will be assigned to each patient and the data will be analyzed by a statistician | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Molecular Tests Base on RNA Expression | The secondary objective is to develop new molecular signatures for distinct clusters of mesothelioma samples grouped according to their gene expression. RNA expression data will be compared between one cluster and all the other clusters and using a variety of statistical and bioinformatics tools. Two-hundred sixteen MPM cases with available RNAseq data will be divided into training and test sets to develop and test potential signatures. The signatures that define each cluster with high sensitivity and specificity will then be tested using RTPCR in a cohort of 555 prospective-collected samples. | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mesothelioma