Mesothelioma Early Detection by VOCs

Pleural Mesothelioma Clinical Trial

— MED-VOC  

Official title:

Identification of Biomarkers for the Early Detection of Mesothelioma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04106973
• Other study ID #: 1432436
• Status: Terminated
• Start date: June 5, 2019
• Est. completion date: January 1, 2022

Study information

• Verified date: September 2022
• Source: Ascension South East Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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..

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asbestos Exposure
• Mesothelioma
• Mesothelioma, Malignant
• Pleural Mesothelioma
• Pleural Plaque

Locations

Country	Name	City	State
United States	Consultants in Sleep and Pulmonary Medicine	Farmington Hills	Michigan

Sponsors (4)

Lead Sponsor	Collaborator
Ascension South East Michigan	Fujirebio Diagnostics, Inc., International Association of Heat and Frost Insulators and Allied Workers, Owlstone Ltd

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

Oliver 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At study completion, approximately 2 years
Secondary	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	At study completion, approximately 2 years