Mesothelioma Early Detection by VOCs

NCT04106973 | Terminated

• 1 other identifier: 1432436
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pleural Mesothelioma; Bilateral Pleural Plaques; Asbestos Exposure; Exhaled breath analysis; VOCs

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Predictive capability, sensitivity and specificity of Soluble Mesothelin Related Peptides (SMRP) in serum when combined with VOC biomarkers for pleural mesothelioma.

  At study completion, approximately 2 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry Ford Health System: lead
• International Association of Heat and Frost Insulators and Allied Workers: collaborator
• Owlstone Ltd: collaborator
• Fujirebio Diagnostics, Inc.: collaborator

Study Sites (1)

Consultants in Sleep and Pulmonary Medicine

Farmington Hills, Michigan, 48336, United States

Location

Related 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.

  PMID: 20924566 BACKGROUND

• 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. doi: 10.1016/j.acra.2004.09.010. No abstract available.

  PMID: 15596380 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Exhaled breath collected in four stainless steel sorbent tubes and serum specimen and serum specimen from each subject.

MeSH Terms

Conditions

Mesothelioma, Malignant

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Michael R Harbut, MD, MPH

  Ascension Providence Hospital, Southfield

  PRINCIPAL INVESTIGATOR

• David M Svinarich, PhD

  Ascension Providence South East Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: VP-Research

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: September 27, 2019
• Study Start: June 5, 2019
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: September 14, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)