Mesothelioma Early Detection by VOCs (MED-VOC)

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.

Primary Outcome Measures

  1. 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. [ Time Frame: By March 31, 2021 ]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.

Secondary Outcome Measures

  1. Predictive capability, sensitivity and specificity of Soluble Mesothelin Related Peptides (SMRP) in serum when combined with VOC biomarkers for pleural mesothelioma. [ Time Frame: By March 31, 2021 ]Determine the additive predictive capability, sensitivity and specificity of SMRP serum biomarkers with VOC biomarkers for the early detection of pleural mesothelioma

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

« Mesothelioma Clinical Trials Main Page.

Source: the U.S. National Institutes of Health via ClinicalTrials.gov. Last updated: October 11th, 2019.

You can follow any responses to this entry through the RSS 2.0 feed.

Both comments and pings are currently closed.

Comments are closed.

Last update: May 07, 2019. 08:38:48 pm.