Clinical trial · Observational
Mesothelioma Early Detection by VOCs
Identification of Biomarkers for the Early Detection of Mesothelioma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Recruitment suspended secondary to social distancing directive associated with Covid-19
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Asbestos Exposure | — | UNRESOLVED | — |
| Pleural Mesothelioma | Pleural Mesothelial Neoplasm | ALIAS | 0.90 |
| Pleural Plaque | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Pleural mesothelioma
- description
- Participants with all types of histologically identified pleural mesothelioma prior to, subsequent to,or concurrent with treatment.
- label
- Asbestos exposed without pleural mesothelioma
- description
- Participants with asbestos exposure radiographically confirmed by the presence of bilateral pleural plaques or bilateral pleural thickening and without presence of pleural mesothelioma.
Primary outcomes (1)
- 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.
- timeFrame
- At study completion, approximately 2 years
- description
- 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 outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDde 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. PMID 20924566
- BACKGROUNDOliver 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. PMID 15596380