Pleural MesotheliomaMED-VOCNCT04106973
Mesothelioma Early Detection by VOCs
An observational study of Pleural Mesothelioma and Asbestos Exposure, run by Henry Ford Health System at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Mesothelioma, Asbestos Exposure, Pleural Plaque
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2019to 1 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Consultants in Sleep and Pulmonary Medicine
Farmington Hills, Michigan, 48336
About this study
Official title: 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.
Read the 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..
- Conditions
- Pleural Mesothelioma, Asbestos Exposure, Pleural Plaque
- Keywords
- Pleural Mesothelioma, Bilateral Pleural Plaques, Asbestos Exposure, Exhaled breath analysis, VOCs
- Medical subject headings
- Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: At study completion, approximately 2 years
Secondary outcomes (1)
Predictive capability, sensitivity and specificity of Soluble Mesothelin Related Peptides (SMRP) in serum when combined with VOC biomarkers for pleural mesothelioma.
Determine the additive predictive capability, sensitivity and specificity of SMRP serum biomarkers with VOC biomarkers for the early detection of pleural mesothelioma
Measured: At study completion, approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start5 Jun 2019
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Why it stopped: Recruitment suspended secondary to social distancing directive associated with Covid-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pleural MesotheliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- International Association of Heat and Frost Insulators and Allied Workers, Owlstone Ltd, Fujirebio Diagnostics, Inc.
- Responsible party
- Sponsor
- Investigators
- Michael R Harbut, MD, MPH, Principal investigator, Ascension Providence Hospital, SouthfieldDavid M Svinarich, PhD, Principal investigator, Ascension Providence South East Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04106973
- Sponsor's protocol ID
- 1432436
- Acronym
- MED-VOC
- Status last verified
- Aug 2026
- First submitted
- 25 Sep 2019
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Gennaro G, Dragonieri S, Longobardi F, Musti M, Stallone G, Trizio L, Tutino M. Chemical characterization of exhaled breath to differentiate between patients with malignant plueral mesothelioma from subjects with similar professional asbestos exposure. Anal Bioanal Chem. 2010 Dec;398(7-8):3043-50. doi: 10.1007/s00216-010-4238-y. Epub 2010 Oct 6.
PubMed 20924566Oliver LC, Welch LS, Harbut MR. Comparison of B readers' interpretations of chest radiographs for asbestos related changes. Acad Radiol. 2004 Dec;11(12):1397-9; author reply 1402-4. doi: 10.1016/j.acra.2004.09.010. No abstract available.
PubMed 15596380
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Biomarkers for the Early Detection of Mesothelioma
- ClinicalTrials.gov ID
- NCT04106973
- Acronym / sponsor ID
- MED-VOC / 1432436
- Conditions
- Pleural Mesothelioma, Asbestos Exposure, Pleural Plaque
- Keywords
- Pleural Mesothelioma, Bilateral Pleural Plaques, Asbestos Exposure, Exhaled breath analysis, VOCs
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment suspended secondary to social distancing directive associated with Covid-19
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- International Association of Heat and Frost Insulators and Allied Workers, Owlstone Ltd, Fujirebio Diagnostics, Inc.
- Study start
- 5 Jun 2019 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 27 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: Recruitment suspended secondary to social distancing directive associated with Covid-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Background: PubMed 20924566de Gennaro G, Dragonieri S, Longobardi F, Musti M, Stallone G, Trizio L, Tutino M. Chemical characterization of exhaled breath to differentiate between patients with malignant plueral mesothelioma from subjects with similar professional asbestos exposure. Anal Bioanal Chem. 2010 Dec;398(7-8):3043-50. doi: 10.1007/s00216-010-4238-y. Epub 2010 Oct 6.
- Background: PubMed 15596380Oliver LC, Welch LS, Harbut MR. Comparison of B readers' interpretations of chest radiographs for asbestos related changes. Acad Radiol. 2004 Dec;11(12):1397-9; author reply 1402-4. doi: 10.1016/j.acra.2004.09.010. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael R Harbut, MD, MPH principal investigator
Ascension Providence Hospital, Southfield
David M Svinarich, PhD principal investigator
Ascension Providence South East Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pleural Mesothelioma and Asbestos Exposure, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment suspended secondary to social distancing directive associated with Covid-19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04106973, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.