Volatiles in Breath and Headspace Analysis – Diagnostic Markers

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Brief Title

Volatiles in Breath and Headspace Analysis - Diagnostic Markers

Official Title

Volatile Organic Compounds in Breath and Headspace Analysis - Diagnostic and Monitoring Markers for Diseases

Brief Summary

      Detection of Volatile Organic Compounds (VOC) directly from tissue by headspace analysis
      (skin, surgery material, other tissue) and exhaled breath is feasible using affordable
      user-friendly novel nano-chemo sensors that can accurately be used for screening and
      monitoring purpose
    

Detailed Description

      Study propose to explore a novel approach for the diagnosis and monitoring of diseases. The
      approach is based on the detection of volatile organic compounds (VOCs) that are emitted from
      the cells and detected directly from tissue, such as skin, surgery material, blood as well as
      from exhaled breath.

      In the literature there are several reports on VOCs which can be detected by Gas
      Chromatography - Mass Spectrometry (GC-MS) means directly from: (i) the headspace of TB cells
      (i.e., the mixture of volatile biomarkers trapped above the TB cells in a sealed vessel);
      (ii) the exhaled breath or (iii) from urine. Excellent results in detection of the
      tuberculosis disease by using nanosensor array were shown by Nakhleh et al achieved 90%
      sensitivity, 93% specificity and 92% accuracy in discrimination between healthy and diseased
      patients using electronic nose devices with a single sensor. None of the reported studies
      identified the tentative recognition of the tuberculosis-related VOCs and quantified the
      concentration differences between samples from ill and healthy controls. Further
      investigation of the exhaled breath tuberculosis-related VOC by GC-MS means will improve the
      knowledge and simultaneously will help to improve the nanosensor array design.

      Several studies have shown that disease-rated VOC patterns can be transmitted through the
      skin, and, therefore, skin can be used as a source for disease detection and identification.
      The principle of this detection approach is that disease-related changes are reflected in
      measurable changes in the skin through exchange via the blood. In addition, several studies
      have suggested that the VOC levels are elevated even in early stages of the disease, because
      they reflect a change in the human's body chemistry (as a result of the development of
      disease condition), rather than the amount of infected cells. Complementary studies have
      shown that VOCs can be emitted to the skin within minutes after they have emerged in the
      infected part of the human's body. What is particularly significant about this approach is
      that each type of (infectious) disease has its own unique pattern of VOCs, and, therefore,
      the presence of one (infectious) disease would not screen other disease types. Nevertheless,
      to the best of our knowledge, the detection of tuberculosis VOCs through skin has not been
      examined yet. Additionally, all studies targeting skin VOCs have been carried out by means of
      spectrometry and spectroscopy techniques. In few cases, electronic nose devices were used.
      These techniques are powerful tools for detecting VOCs. However, to date, the use of these
      techniques has been impeded by the need for moderately to highly expensive equipment's, the
      high levels of expertise required to operate such instruments, the speed required for
      sampling and analysis, and the need for preconcentration techniques. For VOC skin testing and
      breath testing of tuberculosis to become widely used in clinical practice, several advances
      in the knowledge of tuberculosis specific VOCs and sensor development need to occur.
      Nanoparticles containing flexible sensors, based on organic films, are more likely to become
      a clinical diagnostic tool, because they are significantly smaller, easier-to-use, and
      significantly less expensive.

      In recent years comprehensive studies have shown excellent data for using VOCs from exhaled
      breath as tool for diagnosing gastric cancer. In one of the biggest studies carried out by
      Chinese and Latvian centers, malignancy could be identified with 89% sensitivity and 90%
      specificity after cross-validation, irrespective of important confounding factors in gastric
      patients such as tobacco or alcohol consumption and H. pylori infection. A breath test for GC
      staging could also be demonstrated by distinguishing stage I&II cancers from stage III&IV
      cancers with 89% sensitivity and 94% specificity. These studies used both - mass spectometry
      and nano-sensors technologies. Most recent study published in ASC Nano journal in January
      2017 reported on more extended use of nanoarry sensors in breath analysis, blind experiments
      showed that 86% accuracy could be achieved with the artificially intelligent nanoarray,
      allowing both detection and discrimination between the different disease conditions examined
      (chronic kidney failure, idiopathic Parkinson's disease, atypical Parkinsonism , multiple
      sclerosis, Crohn's disease, ulcerative colitis, irritable bowel syndrome, pulmonary arterial
      hypertension, pre-eclampsia in pregnant women, head and neck cancer, lung cancer, colorectal
      cancer, bladder cancer, kidney cancer, prostate cancer, gastric cancer, and ovarian cancer.
      Analysis of the artificially intelligent nanoarray also showed that each disease has its own
      unique breathprint, and that the presence of one disease would not screen out others.

      Therefore, this study is aimed to test VOCs detecting technologies as diagnostic and
      monitoring tools for digestive tract and infectious diseases.
    


Study Type

Observational


Primary Outcome

Specific VOC detected

Secondary Outcome

 Specific VOC patterns for target disease or lesion and risk groups

Condition

Tuberculosis

Intervention

VOC detection in breath and in skin headspace

Study Arms / Comparison Groups

 Active Tuberculosis
Description:  Participants with Active Tuberculosis Disease Intervention: Diagnostic Test: VOC detection in breath and in skin headspace Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Breath sampling Intervention: Headspace analysis for biological material

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

3000

Start Date

July 24, 2017

Completion Date

December 31, 2025

Primary Completion Date

December 20, 2019

Eligibility Criteria

        Inclusion Criteria:

          -  Informed Consent signed

          -  Individual with targeted disease/lesion (tuberculosis, gastric cancer, gastric
             dysplasia, high/ normal/ low risk gastric lesions, colorectal cancer, high-risk
             colorectal lesions, low-risk colorectal adenoma, pancreatic cancer, chronic
             pancreatitis, liver cancer, chronic liver disease, other infectious diseases,
             oncological diseases of other location)

        Exclusion Criteria:

          -  Informed Consent not signed

          -  Other active cancer at the time of inclusion for particular study group
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Mārcis Leja, PhD, MD, , 

Location Countries

Latvia

Location Countries

Latvia

Administrative Informations


NCT ID

NCT03228095

Organization ID

2017/20329


Responsible Party

Sponsor

Study Sponsor

University of Latvia

Collaborators

 Technion, Israel Institute of Technology

Study Sponsor

Mārcis Leja, PhD, MD, Study Director, University of Latvia


Verification Date

August 2018