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

Digestive System Diseases

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Stomach Neoplasms

Breast Neoplasms

Neoplastic Cells, Circulating

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Neoplasm Metastasis

Neoplastic Processes

Stomach Cancer

patients with definitive diagnosis of gastric cancer by pathology

patients with definitive diagnosis of breast cancer by pathology

Hyperplasia of mammary glands or mastitis

Alveolar exhaled breath samples and peripheral venous blood(10ml) will be collected from each patients

Circulating tumor cells, Volatile organic compounds

Chuyang Bao, MD

Hu Liu, MD

Early diagnosis of malignant tumors is pivotal for improving their prognoses. Circulating tumor cells (CTC) in peripheral blood and Volatile organic compounds (VOCs) in exhaled breath are newly developed diagnosis method. Due to the low percentage of CTCs in peripheral blood of cancer patients and the surface structure of lymphocytes (especially megakaryocytes) is often confused with tumor cells, CTC has a high false positive and negative rate. In recent years, the detection of volatile organic compounds (VOCs) in exhaled breath as a simple and noninvasive method has shown broad application prospects in the diagnosis of various diseases. A series of studies of VOCs diagnosing solid tumors the investigators had conducted in the past decade show that VOCs can not only distinguish different types of tumors, but also can make a distinction between different stages. This study was to compare CTC and VOCs with clinical samples. Predictive models will be built employing discriminant factor analysis (DFA) pattern recognition method. Sensitivity and specificity will be determined using leave-one-out cross-validation or an independent blind test set.

200 patients with definitive diagnoses will be enrolled and the alveolar exhaled breath samples and peripheral venous blood will be collected. Two blood samples and two breath samples will be collected from each patient. One blood sample will be send to CTC tests for a blind test and the other will be used for headspace VOCs analyses. One breath sample was used for analysis with the Nano-sensors array, and the other was used for gas chromatography coupled with mass spectrometry (GC-MS) analysis. The VOCs samples were collected using sorbent tubes at a total flow through sorption trap of 200ml/min, then will be send to Israel Institute of Technology for further test.

Diagnostic Power Comparison Between VOCs and CTCs

The Diagnostic Power of VOCs Compared With CTCs for Cancer

Exhaled breath samples and peripheral venous blood collected will be used to build predictive models employing discriminant factor analysis (DFA) and thereafter examine the sensitivity and specificity of model identification.

Organize predictive models of VOCs/CTCs and establish Comprehensive Diagnostic Model.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Mesothelioma Early Detection by VOCs	NCT04106973	Pleural Mesothe... Asbestos Exposu... Pleural Plaque		18 Years -	Ascension South East Michigan
Diagnostic Power Comparison Between VOCs and CTCs	NCT03958812	Circulating Tum... Volatile Organi... Breast Cancer Gastric Cancer Diagnoses Disea...	Circulating tum...	18 Years - 75 Years	Anhui Medical University

Spots Global Cancer Trial Database for vocs

Every month we try and update this database with for vocs cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for vocs

Every month we try and update this database with for vocs cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for vocs cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.