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Mesothelioma Early Detection by VOCs (MED-VOC)

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ClinicalTrials.gov Identifier: NCT04106973
Recruitment Status : Recruiting
First Posted : September 27, 2019
Last Update Posted : September 27, 2019
Sponsor:
Collaborators:
International Association of Heat and Frost Insulators and Allied Workers Union
Owlstone Ltd
Fujirebio Diagnostics, Inc.
Information provided by (Responsible Party):
David Svinarich, Ph.D., Ascension South East Michigan

Brief Summary:
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.

Condition or disease
Pleural Mesothelioma Asbestos Exposure Pleural Plaque

Detailed Description:

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..


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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
Pleural mesothelioma
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.



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


Biospecimen Retention:   Samples Without DNA
Exhaled breath collected in four stainless steel sorbent tubes and serum specimen and serum specimen from each subject.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals with histologically confirmed pleural mesothelioma, and individuals with an asbestos exposure and radiological evidence of bilateral pleural plaques or pleural thickening without evidence of mesothelioma. The majority of asbestos exposed participants with bilateral pleural thickening or pleural plaques and no mesothelioma will be active or retired members of the International Association of Heat and Frost Insulators and Allied Workers Union.
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Cyndi Noraian, RN 248-350-2722 ext 202 cynthia.noraian@ascension.org
Contact: David Svinarich, PhD. 586-753-0270 david.svinarich@ascension.org

Locations
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United States, Michigan
Consultants in Sleep and Pulmonary Medicine Recruiting
Farmington Hills, Michigan, United States, 48336
Contact: Cyndi Noraian, RN    248-350-2722 ext 202    cynthia.noraian@ascension.org   
Contact: David M Svinarich, PhD    586-753-0270    david.svinarich@ascension.org   
Principal Investigator: Michael R Harbut, MD, MPH         
Principal Investigator: David M Svinarich, PhD         
Sponsors and Collaborators
Ascension South East Michigan
International Association of Heat and Frost Insulators and Allied Workers Union
Owlstone Ltd
Fujirebio Diagnostics, Inc.
Investigators
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Principal Investigator: Michael R Harbut, MD, MPH Ascension Providence Hospital, Southfield
Principal Investigator: David M Svinarich, PhD Ascension Providence South East Michigan

Publications of Results:
Other Publications:
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Responsible Party: David Svinarich, Ph.D., VP-Research, Ascension South East Michigan
ClinicalTrials.gov Identifier: NCT04106973     History of Changes
Other Study ID Numbers: 1432436
First Posted: September 27, 2019    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Svinarich, Ph.D., Ascension South East Michigan:
Pleural Mesothelioma
Bilateral Pleural Plaques
Asbestos Exposure
Exhaled breath analysis
VOCs
Additional relevant MeSH terms:
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Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial