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Sponsor: Henry Ford Health System
Conditions: Pleural Mesothelioma, Asbestos Exposure, Pleural Plaque
Countries: United States
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.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: OBSERVATIONAL
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
- Farmington Hills, Michigan, United States