Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Mesothelioma

Mesothelioma, Malignant

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Mesothelial

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Pleural Neoplasms

Lung Diseases

Respiratory Tract Diseases

Malignant Mesothelioma

Participants with all types of histologically identified pleural mesothelioma prior to, subsequent to,or concurrent with treatment.

Participants with asbestos exposure radiographically confirmed by the presence of bilateral pleural plaques or bilateral pleural thickening and without presence of pleural mesothelioma.

Michael R Harbut, MD, MPH

David M Svinarich, PhD

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.

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..

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

Mesothelioma Early Detection by VOCs

Identification of Biomarkers for the Early Detection of Mesothelioma

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.

Determine the additive predictive capability, sensitivity and specificity of SMRP serum biomarkers with VOC biomarkers for the early detection of pleural mesothelioma

International Association of Heat and Frost Insulators and Allied Workers

Owlstone Ltd

Fujirebio Diagnostics, Inc.

Ascension South East Michigan

VP-Research

Occupational Diseases

Pleural Diseases

Asbestosis

Herbal and Botanical

All Drugs and Chemicals

Artichoke

Artichoke WPC 500 mg capsules. Dose = 1000 mg (2 - 500 mg capsules) just before breakfast and 1000 mg (2 - 500 mg capsules) before dinner. Duration: daily for a period of 90 days.

Artichoke WPC

Paola Muti

This is a single-arm phase II trial to assess the biological activity (in a sub-cohort using a Simon two-stage Phase II design) and toxicity of Artichoke Whole Phytocomplex Concentrate (WPC). The objective of the study is to explore the potential for a non-toxic phytocomplex extract from the artichoke plant as a chemoprevention agent.

In individuals exposed to asbestos and affected with asbestosis or asbestos-related benign pleural disease, and therefore at increased risk of mesothelioma, the investigators will evaluate whether the treatment with the commercially-available Artichoke Whole Phytocomplex Concentrate (Artichoke WPC) for 90 days will decrease mesothelin serum levels.

Although the investigators have general information on toxicity in humans, the investigators will monitor and assess the potential toxicity of Artichoke WPC in this patient population.

In addition to mesothelin, the investigators plan to evaluate the effects of Artichoke WPC on serum microRNAs (miRNAs). The use of miRNAs as minimally-invasive biomarkers has opened new opportunities for the diagnosis of cancer. A number of studies have addressed the potential association of disregulated miRNA profiling and benign asbestos-related disease and mesothelioma. Thus, the investigators will evaluate serum miRNA profiling before and after treatment with Artichoke WPC.

Investigation of the Anti-Cancer Activity of Artichoke Extract in an Asbestos-Exposed Population

Investigation of the Anti-Cancer Activity of Artichoke Extract in an Asbestos-Exposed Population (The ABOCA Phase II Trial)

The primary efficacy outcome is based on the reduction in serum concentration levels of mesothelin, measured at baseline and at the end of the intervention for subjects in the efficacy sub-cohort (i.e. for subjects who had elevated mesothelin levels at baseline). A positive outcome will be declared if the biomarker shows a reduction of 25% or more of its baseline value over the 90-day treatment period. For each study subject, mesothelin serum levels for both the baseline and final blood draws will be determined at the same time and in the same batch. This will assist in minimizing the technical variability of the assessments.

At the Day 45 and Day 90 visits, adverse reactions will be reported and graded according to the NCI CTCAE Version 4.03.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Mesothelioma Early Detection by VOCs	NCT04106973	Pleural Mesothe... Asbestos Exposu... Pleural Plaque		18 Years -	Ascension South East Michigan
Investigation of the Anti-Cancer Activity of Artichoke Extract in an Asbestos-Exposed Population	NCT02076672	Asbestos Exposu...	Artichoke WPC	18 Years - 80 Years	Ontario Clinical Oncology Group (OCOG)
Investigation of the Anti-Cancer Activity of Artichoke Extract in an Asbestos-Exposed Population	NCT02076672	Asbestos Exposu...	Artichoke WPC	18 Years - 80 Years	Ontario Clinical Oncology Group (OCOG)

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