Mesothelioma Early Detection by VOCs (MED-VOC)

September 8, 2022 updated by: David Svinarich, Ph.D., Ascension South East Michigan

Identification of Biomarkers for the Early Detection of Mesothelioma

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.

Study Overview

Status

Terminated

Conditions

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..

Study Type

Observational

Enrollment (Actual)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Farmington Hills, Michigan, United States, 48336
        • Consultants in Sleep and Pulmonary Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At study completion, approximately 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At study completion, approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ascension South East Michigan

Collaborators

Fujirebio Diagnostics, Inc.
International Association of Heat and Frost Insulators and Allied Workers
Owlstone Ltd

Investigators

  • Principal Investigator: Michael R Harbut, MD, MPH, Ascension Providence Hospital, Southfield
  • Principal Investigator: David M Svinarich, PhD, Ascension Providence South East Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2019

Primary Completion (Actual)

January 1, 2022

Study Completion (Actual)

January 1, 2022

Study Registration Dates

First Submitted

September 25, 2019

First Submitted That Met QC Criteria

September 26, 2019

First Posted (Actual)

September 27, 2019

Study Record Updates

Last Update Posted (Actual)

September 14, 2022

Last Update Submitted That Met QC Criteria

September 8, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1432436

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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