Mesothelioma Early Detection by VOCs (MED-VOC)
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|ClinicalTrials.gov Identifier: NCT04106973|
Recruitment Status : Suspended (Recruitment suspended secondary to social distancing directive associated with Covid-19)
First Posted : September 27, 2019
Last Update Posted : May 13, 2020
|Condition or disease|
|Pleural Mesothelioma Asbestos Exposure Pleural Plaque|
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..
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Identification of Biomarkers for the Early Detection of Mesothelioma|
|Actual Study Start Date :||June 5, 2019|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2022|
Participants with all types of histologically identified pleural mesothelioma prior to, subsequent to,or concurrent with treatment.
Asbestos exposed without pleural mesothelioma
Participants with asbestos exposure radiographically confirmed by the presence of bilateral pleural plaques or bilateral pleural thickening and without presence of pleural mesothelioma.
- 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: At study completion, approximately 2 years ]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 Soluble Mesothelin Related Peptides (SMRP) in serum when combined with VOC biomarkers for pleural mesothelioma. [ Time Frame: At study completion, approximately 2 years ]Determine the additive predictive capability, sensitivity and specificity of SMRP serum biomarkers with VOC biomarkers for the early detection of pleural mesothelioma
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04106973
|United States, Michigan|
|Consultants in Sleep and Pulmonary Medicine|
|Farmington Hills, Michigan, United States, 48336|
|Principal Investigator:||Michael R Harbut, MD, MPH||Ascension Providence Hospital, Southfield|
|Principal Investigator:||David M Svinarich, PhD||Ascension Providence South East Michigan|