Mesothelioma Early Detection by VOCs

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..

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