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Mesothelioma Early Detection by VOCs

NCT04106973 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2022-09-14

No results posted yet for this study

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.

Conditions

  • Pleural Mesothelioma
  • Asbestos Exposure
  • Pleural Plaque

Sponsors & Collaborators

  • International Association of Heat and Frost Insulators and Allied Workers

    collaborator OTHER

  • Owlstone Ltd

    collaborator INDUSTRY

  • Fujirebio Diagnostics, Inc.

    collaborator INDUSTRY

  • Henry Ford Health System

    lead OTHER

Principal Investigators

  • Michael R Harbut, MD, MPH · Ascension Providence Hospital, Southfield

  • David M Svinarich, PhD · Ascension Providence South East Michigan

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-05
Primary Completion
2022-01-01
Completion
2022-01-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04106973 on ClinicalTrials.gov