Mesothelioma Early Detection by VOCs

Study Overview
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Brief Summary
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This is a two phase study, The first phase (phase 1) will identify potential biomarkers among asbestos exposed individuals with pleural mesothelioma. The second phase (phase 2), is a double blinded case-matched controlled study to determine the predictive capability, sensitivity, and specificity of these biomarkers in detecting early stage pleural mesothelioma. Biomarkers in the form of volatile organic compounds (VOC) in exhaled breath samples from subjects with either pleural mesothelioma or pleural plaques, will be evaluated. A biomarker present in serum will also be concurrently evaluated in the same cohort. The soluble serum biomarker mesothelin related peptides (SMRP), which has been posited as a biomarker for mesothelioma, will be analyzed for its relationship to the breath VOC profile.

Detailed Description
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Mesothelioma is a rare, aggressive and treatment-resistant disease and, in the United States, is caused almost exclusively by exposure to asbestos fibers. There is often a lengthy latency period of 40-50 years between exposure and disease onset. The median age of diagnosis is 65 years while the median survival time after diagnosis of pleural mesothelioma without treatment is 9 months. Symptoms, where present, may be non-specific, which further contributes to delayed diagnosis. In this study, the volatile organic compound (VOC) profile of exhaled breath from subjects with histologically confirmed mesothelioma will be compared against case-matched control subjects with bilateral pleural plaques or bilateral pleural thickening. Putative markers will then be tested against a blinded cohort to test predictive value of the markers. This study seeks to identify markers for mesothelioma using a non-invasive technique which samples volatile organic compounds (VOC) in the breath of test subjects (Owlstone Medical Ltd, Cambridge, England). A comparison of the participant's VOC profile will be made with an FDA-approved, serum-based assay (Lumipulse Mesomark®, Fujirebio Diagnostics Inc., Malvern, PA) of the participant's soluble mesothelin related peptides (SMRP) to discern parameters of efficacy..

Official Title
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Identification of Biomarkers for the Early Detection of Mesothelioma

Conditions
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Pleural Mesothelioma, Asbestos Exposure, Pleural Plaque

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Male or Female over 18 years of age Clinical diagnosis of pleural mesothelioma or presence of pleural plaques on X-Ray Documented exposure to asbestos Must be able to provide breath sample Must be able to provide relevant medical information Exclusion Criteria Presence of malignancies other that mesothelioma within the past 6 months Treatment for any malignancies other than mesothelioma within the past 6 months Inability to provide past clinical information Inability to perform breath collection procedure Smoking or consuming alcohol within two hours of conducting breath collection procedure

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pleural mesothelioma<br>Participants with all types of histologically identified pleural mesothelioma prior to, subsequent to,or concurrent with treatment. | |
| Asbestos exposed without pleural mesothelioma<br>Participants with asbestos exposure radiographically confirmed by the presence of bilateral pleural plaques or bilateral pleural thickening and without presence of pleural mesothelioma. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VOC markers in breath samples. Predictive capability, sensitivity and specificity of biomarkers present in volatile organic compounds (VOC) for the early detection of pleural Mesothelioma in patients exposed to asbestos. | Predictive capability, sensitivity and specificity of biomarkers present in volatile organic compounds (VOC) for the early detection of pleural Mesothelioma in patients exposed to asbestos. | At study completion, approximately 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive capability, sensitivity and specificity of Soluble Mesothelin Related Peptides (SMRP) in serum when combined with VOC biomarkers for pleural mesothelioma. | Determine the additive predictive capability, sensitivity and specificity of SMRP serum biomarkers with VOC biomarkers for the early detection of pleural mesothelioma | At study completion, approximately 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pleural Mesothelioma, Bilateral Pleural Plaques, Asbestos Exposure, Exhaled breath analysis, VOCs