<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03228095</url>
  </required_header>
  <id_info>
    <org_study_id>2017/20329</org_study_id>
    <nct_id>NCT03228095</nct_id>
  </id_info>
  <brief_title>Volatiles in Breath and Headspace Analysis - Diagnostic Markers</brief_title>
  <acronym>Volatolome</acronym>
  <official_title>Volatile Organic Compounds in Breath and Headspace Analysis - Diagnostic and Monitoring Markers for Diseases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Latvia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Technion, Israel Institute of Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Riga East University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>JLM Innovation GmbH</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Latvia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Detection of Volatile Organic Compounds (VOC) directly from tissue by headspace analysis&#xD;
      (skin, surgery material, other tissue) and exhaled breath is feasible using affordable&#xD;
      user-friendly novel nano-chemo sensors that can accurately be used for screening and&#xD;
      monitoring purpose&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study propose to explore a novel approach for the diagnosis and monitoring of diseases. The&#xD;
      approach is based on the detection of volatile organic compounds (VOCs) that are emitted from&#xD;
      the cells and detected directly from tissue, such as skin, surgery material, blood as well as&#xD;
      from exhaled breath.&#xD;
&#xD;
      In the literature there are several reports on VOCs which can be detected by Gas&#xD;
      Chromatography - Mass Spectrometry (GC-MS) means directly from: (i) the headspace of TB cells&#xD;
      (i.e., the mixture of volatile biomarkers trapped above the TB cells in a sealed vessel);&#xD;
      (ii) the exhaled breath or (iii) from urine. Excellent results in detection of the&#xD;
      tuberculosis disease by using nanosensor array were shown by Nakhleh et al achieved 90%&#xD;
      sensitivity, 93% specificity and 92% accuracy in discrimination between healthy and diseased&#xD;
      patients using electronic nose devices with a single sensor. None of the reported studies&#xD;
      identified the tentative recognition of the tuberculosis-related VOCs and quantified the&#xD;
      concentration differences between samples from ill and healthy controls. Further&#xD;
      investigation of the exhaled breath tuberculosis-related VOC by GC-MS means will improve the&#xD;
      knowledge and simultaneously will help to improve the nanosensor array design.&#xD;
&#xD;
      Several studies have shown that disease-rated VOC patterns can be transmitted through the&#xD;
      skin, and, therefore, skin can be used as a source for disease detection and identification.&#xD;
      The principle of this detection approach is that disease-related changes are reflected in&#xD;
      measurable changes in the skin through exchange via the blood. In addition, several studies&#xD;
      have suggested that the VOC levels are elevated even in early stages of the disease, because&#xD;
      they reflect a change in the human's body chemistry (as a result of the development of&#xD;
      disease condition), rather than the amount of infected cells. Complementary studies have&#xD;
      shown that VOCs can be emitted to the skin within minutes after they have emerged in the&#xD;
      infected part of the human's body. What is particularly significant about this approach is&#xD;
      that each type of (infectious) disease has its own unique pattern of VOCs, and, therefore,&#xD;
      the presence of one (infectious) disease would not screen other disease types. Nevertheless,&#xD;
      to the best of our knowledge, the detection of tuberculosis VOCs through skin has not been&#xD;
      examined yet. Additionally, all studies targeting skin VOCs have been carried out by means of&#xD;
      spectrometry and spectroscopy techniques. In few cases, electronic nose devices were used.&#xD;
      These techniques are powerful tools for detecting VOCs. However, to date, the use of these&#xD;
      techniques has been impeded by the need for moderately to highly expensive equipment's, the&#xD;
      high levels of expertise required to operate such instruments, the speed required for&#xD;
      sampling and analysis, and the need for preconcentration techniques. For VOC skin testing and&#xD;
      breath testing of tuberculosis to become widely used in clinical practice, several advances&#xD;
      in the knowledge of tuberculosis specific VOCs and sensor development need to occur.&#xD;
      Nanoparticles containing flexible sensors, based on organic films, are more likely to become&#xD;
      a clinical diagnostic tool, because they are significantly smaller, easier-to-use, and&#xD;
      significantly less expensive.&#xD;
&#xD;
      In recent years comprehensive studies have shown excellent data for using VOCs from exhaled&#xD;
      breath as tool for diagnosing gastric cancer. In one of the biggest studies carried out by&#xD;
      Chinese and Latvian centers, malignancy could be identified with 89% sensitivity and 90%&#xD;
      specificity after cross-validation, irrespective of important confounding factors in gastric&#xD;
      patients such as tobacco or alcohol consumption and H. pylori infection. A breath test for GC&#xD;
      staging could also be demonstrated by distinguishing stage I&amp;II cancers from stage III&amp;IV&#xD;
      cancers with 89% sensitivity and 94% specificity. These studies used both - mass spectometry&#xD;
      and nano-sensors technologies. Most recent study published in ASC Nano journal in January&#xD;
      2017 reported on more extended use of nanoarry sensors in breath analysis, blind experiments&#xD;
      showed that 86% accuracy could be achieved with the artificially intelligent nanoarray,&#xD;
      allowing both detection and discrimination between the different disease conditions examined&#xD;
      (chronic kidney failure, idiopathic Parkinson's disease, atypical Parkinsonism , multiple&#xD;
      sclerosis, Crohn's disease, ulcerative colitis, irritable bowel syndrome, pulmonary arterial&#xD;
      hypertension, pre-eclampsia in pregnant women, head and neck cancer, lung cancer, colorectal&#xD;
      cancer, bladder cancer, kidney cancer, prostate cancer, gastric cancer, and ovarian cancer.&#xD;
      Analysis of the artificially intelligent nanoarray also showed that each disease has its own&#xD;
      unique breathprint, and that the presence of one disease would not screen out others.&#xD;
&#xD;
      Therefore, this study is aimed to test VOCs detecting technologies as diagnostic and&#xD;
      monitoring tools for digestive tract and infectious diseases.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">July 24, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 20, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Specific VOC detected</measure>
    <time_frame>2 years</time_frame>
    <description>Tuberculosis specific VOC detected in breath and in skin headspace</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Performance of nanoarray sensor testing to detect target lesions and diseases</measure>
    <time_frame>At the time of breath sampling</time_frame>
    <description>Sensitivity, specificity, overall accuracy of nanoarray sensor testing for VOCs to detect the target lesions in the blinded analysis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Specific VOC patterns for target disease or lesion and risk groups</measure>
    <time_frame>At the time of breath sampling</time_frame>
    <description>List of VOCs assayed by GC-MS with statistical difference between the study groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VOC pattern changes following treatment</measure>
    <time_frame>At baseline, 3 and/or 6 months after treatment (other time frame according to study group)</time_frame>
    <description>VOC pattern changes after specific required treatment (medical eradication of bacteria/viruses, surgery/endoscopic removal for cancers or high risk lesion)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VOC pattern changes in relapse of disease for early recognition and treatment</measure>
    <time_frame>At baseline, 3 and/or 6 months after treatment (other time frame according to study group)</time_frame>
    <description>VOC pattern changes at the time of surveillance in case of relapse (malignant diseases).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Groups of gastrointestinal microbiota correlating to VOCs</measure>
    <time_frame>At the time of sampling</time_frame>
    <description>List of gastrointestinal microbiota groups (phylum/genus level) with positive correlation to particular VOCs</description>
  </secondary_outcome>
  <number_of_groups>17</number_of_groups>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Tuberculosis</condition>
  <condition>Gastric Cancer</condition>
  <condition>Peptic Ulcer</condition>
  <condition>Atrophic Gastritis</condition>
  <condition>Intestinal Metaplasia</condition>
  <condition>Gastric Dysplasia</condition>
  <condition>Colorectal Cancer</condition>
  <condition>Colorectal Polyp</condition>
  <condition>Colorectal Adenoma</condition>
  <condition>Pancreatic Cancer</condition>
  <condition>Pancreatitis, Chronic</condition>
  <condition>Liver Cancer</condition>
  <condition>Liver Cirrhosis</condition>
  <condition>Flu, Human</condition>
  <condition>Other Infectious Diseases</condition>
  <condition>Inflammatory Bowel Diseases</condition>
  <arm_group>
    <arm_group_label>Active Tuberculosis</arm_group_label>
    <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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group of Control (Tuberculosis)</arm_group_label>
    <description>Participants Without 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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gastric cancer</arm_group_label>
    <description>Patients with histologically confirmed gastric cancer Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Upper endoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Feacal sampling Intervention: Headspace analysis for biological material Intervention: Procedure/Surgery: Histological examination of surgical speciment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gastric dysplasia</arm_group_label>
    <description>Patients without gastric adenocarcinoma but with histologically confirmed dysplasia (either high- or low-grade) of the stomach Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Upper endoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material Intervention: Diagnostic Test: Fecal sampling Intervention: Procedure/Surgery: Histological examination of surgical specimen</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High-risk gastric lesions</arm_group_label>
    <description>Patients graded Stage III-IV according to OLGIM (Operative Link of Gastric Intestinal Metaplasia Assessment) staging system, Stage III-IV according to OLGA (Operative Link for Gastric Atrophy Assessment), and those with incomplete type of intestinal metaplasia, but excluding those with dysplasia Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Upper endoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Procedure/Surgery: Histological examination of surgical specimen Intervention: Headspace analysis for biological material</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal and low-risk gastric lesions</arm_group_label>
    <description>Staged 0-III according to OLGIM. Dysplasia should be excluded Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Upper endoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Headspace analysis for biological material</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Colorectal cancer</arm_group_label>
    <description>Patients with histologically confirmed colorectal cancer (adenocarcinoma) Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Colonoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Headspace analysis for biological material Intervention: Procedure/Surgery: Histological examination of surgical specimen</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Colorectal high-risk lesions</arm_group_label>
    <description>Patients without colorectal adenocarcinoma, but carrying high-risk adenomatous polyps being described by one of the following: 1) size≥1 cm; 2) high-grade dysplasia; 3) villous component. Prior to removal of the lesions Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Colonoscopy with biopsies Intervention: Headspace analysis for biological material Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Procedure/Surgery: Histological examination of surgical specimen</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Colorectal low-risk adenoma</arm_group_label>
    <description>Patients without colorectal adenocarcinoma and without colorectal high-risk lesions Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Colonoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Headspace analysis for biological material</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group of control (colorectal)</arm_group_label>
    <description>Patients having undergone colonoscopy without an evidence for colorectal lesions Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Colonoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Headspace analysis for biological material Intervention: Procedure/Surgery: Histological examination of surgical specimen</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Average risk general population</arm_group_label>
    <description>Average risk population of both genders aged 40-64 at the time of inclusion lacking alarm symptoms for gastrointestinal cancer Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Headspace analysis for biological material</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pancreatic cancer</arm_group_label>
    <description>Patients with histologically confirmed pancreatic cancer Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chronic pancreatitis</arm_group_label>
    <description>Patients with clinically and/or histologically and/or radiologically confirmed chronic pancreatitis Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Liver cancer</arm_group_label>
    <description>Patients with histologically confirmed primary liver cancer Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chronic liver disease</arm_group_label>
    <description>Patients with histologically confirmed liver cirrhosis of viral or other ethiology Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Upper respiratory tract acute infections</arm_group_label>
    <description>Patients with serologically confirmed infectious disease or individuals of high risk (e.g. population in season of flu epidemy). This group does not include tuberculosis Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oncological diseases of other locations</arm_group_label>
    <description>Patients with histologically confirmed oncological diseases, excluding gastric, colorectal, pancreatic and primary liver cancer Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>VOC detection in breath and in skin headspace</intervention_name>
    <description>VOC will be detected in breath with off-line and on-line testing and in skin headspace with off-line testing</description>
    <arm_group_label>Active Tuberculosis</arm_group_label>
    <arm_group_label>Group of Control (Tuberculosis)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Breath sampling</intervention_name>
    <description>Breath sampling for VOCs detections will be carried out using nano-sensor based devices (electronic nose)</description>
    <arm_group_label>Active Tuberculosis</arm_group_label>
    <arm_group_label>Average risk general population</arm_group_label>
    <arm_group_label>Chronic liver disease</arm_group_label>
    <arm_group_label>Chronic pancreatitis</arm_group_label>
    <arm_group_label>Colorectal cancer</arm_group_label>
    <arm_group_label>Colorectal high-risk lesions</arm_group_label>
    <arm_group_label>Colorectal low-risk adenoma</arm_group_label>
    <arm_group_label>Gastric cancer</arm_group_label>
    <arm_group_label>Gastric dysplasia</arm_group_label>
    <arm_group_label>Group of Control (Tuberculosis)</arm_group_label>
    <arm_group_label>Group of control (colorectal)</arm_group_label>
    <arm_group_label>High-risk gastric lesions</arm_group_label>
    <arm_group_label>Liver cancer</arm_group_label>
    <arm_group_label>Normal and low-risk gastric lesions</arm_group_label>
    <arm_group_label>Oncological diseases of other locations</arm_group_label>
    <arm_group_label>Pancreatic cancer</arm_group_label>
    <arm_group_label>Upper respiratory tract acute infections</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Upper endoscopy with biopsies</intervention_name>
    <description>Upper endoscopy with proper biopsy work-up will be used for identification and stratification of gastric lesions as well as acquisition of biopsies for microbiota testing</description>
    <arm_group_label>Gastric cancer</arm_group_label>
    <arm_group_label>Gastric dysplasia</arm_group_label>
    <arm_group_label>High-risk gastric lesions</arm_group_label>
    <arm_group_label>Normal and low-risk gastric lesions</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Colonoscopy with biopsies</intervention_name>
    <description>Colonoscopy with proper biopsy or polypectomy material work-up will be used for identification and stratification of colorectal lesions as well as acquisition of biopsies for microbiota testing</description>
    <arm_group_label>Colorectal cancer</arm_group_label>
    <arm_group_label>Colorectal high-risk lesions</arm_group_label>
    <arm_group_label>Colorectal low-risk adenoma</arm_group_label>
    <arm_group_label>Group of control (colorectal)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Whole blood/ Plasma / serum sampling</intervention_name>
    <description>Whole blood/Plasma/serum sampling will be used to obtain information for group stratification</description>
    <arm_group_label>Active Tuberculosis</arm_group_label>
    <arm_group_label>Average risk general population</arm_group_label>
    <arm_group_label>Chronic liver disease</arm_group_label>
    <arm_group_label>Chronic pancreatitis</arm_group_label>
    <arm_group_label>Colorectal cancer</arm_group_label>
    <arm_group_label>Colorectal high-risk lesions</arm_group_label>
    <arm_group_label>Colorectal low-risk adenoma</arm_group_label>
    <arm_group_label>Gastric cancer</arm_group_label>
    <arm_group_label>Gastric dysplasia</arm_group_label>
    <arm_group_label>Group of Control (Tuberculosis)</arm_group_label>
    <arm_group_label>Group of control (colorectal)</arm_group_label>
    <arm_group_label>High-risk gastric lesions</arm_group_label>
    <arm_group_label>Liver cancer</arm_group_label>
    <arm_group_label>Normal and low-risk gastric lesions</arm_group_label>
    <arm_group_label>Oncological diseases of other locations</arm_group_label>
    <arm_group_label>Pancreatic cancer</arm_group_label>
    <arm_group_label>Upper respiratory tract acute infections</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Faecal sampling</intervention_name>
    <description>Facal samples will be obtained for faecal occult blood testing as well as microbiota analysis</description>
    <arm_group_label>Average risk general population</arm_group_label>
    <arm_group_label>Colorectal cancer</arm_group_label>
    <arm_group_label>Colorectal high-risk lesions</arm_group_label>
    <arm_group_label>Colorectal low-risk adenoma</arm_group_label>
    <arm_group_label>Gastric cancer</arm_group_label>
    <arm_group_label>Gastric dysplasia</arm_group_label>
    <arm_group_label>Group of control (colorectal)</arm_group_label>
    <arm_group_label>High-risk gastric lesions</arm_group_label>
    <arm_group_label>Normal and low-risk gastric lesions</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Histological examination of surgical specimen</intervention_name>
    <description>Routine histological exam for patients undergoing curative or palliative surgery. Indication for surgery are set based on underlying condition. Study does not interfere with decision making for surgical treatment</description>
    <arm_group_label>Colorectal cancer</arm_group_label>
    <arm_group_label>Colorectal high-risk lesions</arm_group_label>
    <arm_group_label>Colorectal low-risk adenoma</arm_group_label>
    <arm_group_label>Gastric cancer</arm_group_label>
    <arm_group_label>Gastric dysplasia</arm_group_label>
    <arm_group_label>High-risk gastric lesions</arm_group_label>
    <arm_group_label>Liver cancer</arm_group_label>
    <arm_group_label>Oncological diseases of other locations</arm_group_label>
    <arm_group_label>Pancreatic cancer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Headspace analysis for biological material</intervention_name>
    <description>VOC analysis from headspace of surgical specimen, biopsy materials, blood/plasma, microbiota etc.</description>
    <arm_group_label>Active Tuberculosis</arm_group_label>
    <arm_group_label>Average risk general population</arm_group_label>
    <arm_group_label>Chronic liver disease</arm_group_label>
    <arm_group_label>Chronic pancreatitis</arm_group_label>
    <arm_group_label>Colorectal cancer</arm_group_label>
    <arm_group_label>Colorectal high-risk lesions</arm_group_label>
    <arm_group_label>Colorectal low-risk adenoma</arm_group_label>
    <arm_group_label>Gastric cancer</arm_group_label>
    <arm_group_label>Gastric dysplasia</arm_group_label>
    <arm_group_label>Group of Control (Tuberculosis)</arm_group_label>
    <arm_group_label>Group of control (colorectal)</arm_group_label>
    <arm_group_label>High-risk gastric lesions</arm_group_label>
    <arm_group_label>Liver cancer</arm_group_label>
    <arm_group_label>Normal and low-risk gastric lesions</arm_group_label>
    <arm_group_label>Oncological diseases of other locations</arm_group_label>
    <arm_group_label>Pancreatic cancer</arm_group_label>
    <arm_group_label>Upper respiratory tract acute infections</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Surgery and biopsy material as well as blood samples will contain himan DNA&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients being referred for diagnostic testing and treatment Healthy individuals from&#xD;
        general population&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed Consent signed&#xD;
&#xD;
          -  Individual with targeted disease/lesion (tuberculosis, gastric cancer, gastric&#xD;
             dysplasia, high/ normal/ low risk gastric lesions, colorectal cancer, high-risk&#xD;
             colorectal lesions, low-risk colorectal adenoma, pancreatic cancer, chronic&#xD;
             pancreatitis, liver cancer, chronic liver disease, other infectious diseases,&#xD;
             oncological diseases of other location)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Informed Consent not signed&#xD;
&#xD;
          -  Other active cancer at the time of inclusion for particular study group&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mārcis Leja, PhD, MD</last_name>
    <role>Study Director</role>
    <affiliation>University of Latvia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lelde Lauka, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Latvia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Andra Cīrule, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Riga East University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Latvia</name>
      <address>
        <city>Riga</city>
        <zip>LV 1586</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Latvia</country>
  </location_countries>
  <reference>
    <citation>Nakhleh MK, Amal H, Jeries R, Broza YY, Aboud M, Gharra A, Ivgi H, Khatib S, Badarneh S, Har-Shai L, Glass-Marmor L, Lejbkowicz I, Miller A, Badarny S, Winer R, Finberg J, Cohen-Kaminsky S, Perros F, Montani D, Girerd B, Garcia G, Simonneau G, Nakhoul F, Baram S, Salim R, Hakim M, Gruber M, Ronen O, Marshak T, Doweck I, Nativ O, Bahouth Z, Shi DY, Zhang W, Hua QL, Pan YY, Tao L, Liu H, Karban A, Koifman E, Rainis T, Skapars R, Sivins A, Ancans G, Liepniece-Karele I, Kikuste I, Lasina I, Tolmanis I, Johnson D, Millstone SZ, Fulton J, Wells JW, Wilf LH, Humbert M, Leja M, Peled N, Haick H. Diagnosis and Classification of 17 Diseases from 1404 Subjects via Pattern Analysis of Exhaled Molecules. ACS Nano. 2017 Jan 24;11(1):112-125. doi: 10.1021/acsnano.6b04930. Epub 2016 Dec 21.</citation>
    <PMID>28000444</PMID>
  </reference>
  <reference>
    <citation>Xu ZQ, Broza YY, Ionsecu R, Tisch U, Ding L, Liu H, Song Q, Pan YY, Xiong FX, Gu KS, Sun GP, Chen ZD, Leja M, Haick H. A nanomaterial-based breath test for distinguishing gastric cancer from benign gastric conditions. Br J Cancer. 2013 Mar 5;108(4):941-50. doi: 10.1038/bjc.2013.44.</citation>
    <PMID>23462808</PMID>
  </reference>
  <reference>
    <citation>Amal H, Leja M, Broza YY, Tisch U, Funka K, Liepniece-Karele I, Skapars R, Xu ZQ, Liu H, Haick H. Geographical variation in the exhaled volatile organic compounds. J Breath Res. 2013 Dec;7(4):047102. doi: 10.1088/1752-7155/7/4/047102. Epub 2013 Nov 1.</citation>
    <PMID>24184568</PMID>
  </reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>August 20, 2018</last_update_submitted>
  <last_update_submitted_qc>August 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Volatile Organic Compounds</keyword>
  <keyword>Tuberculosis</keyword>
  <keyword>Nano-sensors</keyword>
  <keyword>Electronic nose</keyword>
  <keyword>Digestive cancers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tuberculosis</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Infections</mesh_term>
    <mesh_term>Influenza, Human</mesh_term>
    <mesh_term>Adenoma</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
    <mesh_term>Pancreatitis</mesh_term>
    <mesh_term>Liver Cirrhosis</mesh_term>
    <mesh_term>Gastritis</mesh_term>
    <mesh_term>Peptic Ulcer</mesh_term>
    <mesh_term>Gastritis, Atrophic</mesh_term>
    <mesh_term>Pancreatitis, Chronic</mesh_term>
    <mesh_term>Metaplasia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03228095
org study id: 2017/20329
nct id: NCT03228095
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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
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.
observational model: Cohort
time perspective: Prospective
measure: Specific VOC detected
time frame: 2 years
description: Tuberculosis specific VOC detected in breath and in skin headspace
measure: Performance of nanoarray sensor testing to detect target lesions and diseases
time frame: At the time of breath sampling
description: Sensitivity, specificity, overall accuracy of nanoarray sensor testing for VOCs to detect the target lesions in the blinded analysis
measure: Specific VOC patterns for target disease or lesion and risk groups
time frame: At the time of breath sampling
description: List of VOCs assayed by GC-MS with statistical difference between the study groups
measure: VOC pattern changes following treatment
time frame: At baseline, 3 and/or 6 months after treatment (other time frame according to study group)
description: VOC pattern changes after specific required treatment (medical eradication of bacteria/viruses, surgery/endoscopic removal for cancers or high risk lesion)
measure: VOC pattern changes in relapse of disease for early recognition and treatment
time frame: At baseline, 3 and/or 6 months after treatment (other time frame according to study group)
description: VOC pattern changes at the time of surveillance in case of relapse (malignant diseases).
measure: Groups of gastrointestinal microbiota correlating to VOCs
time frame: At the time of sampling
description: List of gastrointestinal microbiota groups (phylum/genus level) with positive correlation to particular VOCs
arm group label: 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
arm group label: Group of Control (Tuberculosis)
description: Participants Without 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
arm group label: Gastric cancer
description: Patients with histologically confirmed gastric cancer Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Upper endoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Feacal sampling Intervention: Headspace analysis for biological material Intervention: Procedure/Surgery: Histological examination of surgical speciment
arm group label: Gastric dysplasia
description: Patients without gastric adenocarcinoma but with histologically confirmed dysplasia (either high- or low-grade) of the stomach Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Upper endoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material Intervention: Diagnostic Test: Fecal sampling Intervention: Procedure/Surgery: Histological examination of surgical specimen
arm group label: High-risk gastric lesions
description: Patients graded Stage III-IV according to OLGIM (Operative Link of Gastric Intestinal Metaplasia Assessment) staging system, Stage III-IV according to OLGA (Operative Link for Gastric Atrophy Assessment), and those with incomplete type of intestinal metaplasia, but excluding those with dysplasia Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Upper endoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Procedure/Surgery: Histological examination of surgical specimen Intervention: Headspace analysis for biological material
arm group label: Normal and low-risk gastric lesions
description: Staged 0-III according to OLGIM. Dysplasia should be excluded Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Upper endoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Headspace analysis for biological material
arm group label: Colorectal cancer
description: Patients with histologically confirmed colorectal cancer (adenocarcinoma) Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Colonoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Headspace analysis for biological material Intervention: Procedure/Surgery: Histological examination of surgical specimen
arm group label: Colorectal high-risk lesions
description: Patients without colorectal adenocarcinoma, but carrying high-risk adenomatous polyps being described by one of the following: 1) size≥1 cm; 2) high-grade dysplasia; 3) villous component. Prior to removal of the lesions Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Colonoscopy with biopsies Intervention: Headspace analysis for biological material Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Procedure/Surgery: Histological examination of surgical specimen
arm group label: Colorectal low-risk adenoma
description: Patients without colorectal adenocarcinoma and without colorectal high-risk lesions Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Colonoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Headspace analysis for biological material
arm group label: Group of control (colorectal)
description: Patients having undergone colonoscopy without an evidence for colorectal lesions Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Colonoscopy with biopsies Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Headspace analysis for biological material Intervention: Procedure/Surgery: Histological examination of surgical specimen
arm group label: Average risk general population
description: Average risk population of both genders aged 40-64 at the time of inclusion lacking alarm symptoms for gastrointestinal cancer Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Diagnostic Test: Fecal sampling Intervention: Headspace analysis for biological material
arm group label: Pancreatic cancer
description: Patients with histologically confirmed pancreatic cancer Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material
arm group label: Chronic pancreatitis
description: Patients with clinically and/or histologically and/or radiologically confirmed chronic pancreatitis Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material
arm group label: Liver cancer
description: Patients with histologically confirmed primary liver cancer Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material
arm group label: Chronic liver disease
description: Patients with histologically confirmed liver cirrhosis of viral or other ethiology Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material
arm group label: Upper respiratory tract acute infections
description: Patients with serologically confirmed infectious disease or individuals of high risk (e.g. population in season of flu epidemy). This group does not include tuberculosis Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material
arm group label: Oncological diseases of other locations
description: Patients with histologically confirmed oncological diseases, excluding gastric, colorectal, pancreatic and primary liver cancer Intervention: Diagnostic Test: Breath sampling Intervention: Procedure/Surgery: Whole blood/ Plasma / serum sampling Intervention: Headspace analysis for biological material
intervention type: Diagnostic Test
intervention name: VOC detection in breath and in skin headspace
description: VOC will be detected in breath with off-line and on-line testing and in skin headspace with off-line testing
arm group label: Active Tuberculosis
arm group label: Group of Control (Tuberculosis)
intervention type: Diagnostic Test
intervention name: Breath sampling
description: Breath sampling for VOCs detections will be carried out using nano-sensor based devices (electronic nose)
arm group label: Active Tuberculosis
arm group label: Average risk general population
arm group label: Chronic liver disease
arm group label: Chronic pancreatitis
arm group label: Colorectal cancer
arm group label: Colorectal high-risk lesions
arm group label: Colorectal low-risk adenoma
arm group label: Gastric cancer
arm group label: Gastric dysplasia
arm group label: Group of Control (Tuberculosis)
arm group label: Group of control (colorectal)
arm group label: High-risk gastric lesions
arm group label: Liver cancer
arm group label: Normal and low-risk gastric lesions
arm group label: Oncological diseases of other locations
arm group label: Pancreatic cancer
arm group label: Upper respiratory tract acute infections
intervention type: Procedure
intervention name: Upper endoscopy with biopsies
description: Upper endoscopy with proper biopsy work-up will be used for identification and stratification of gastric lesions as well as acquisition of biopsies for microbiota testing
arm group label: Gastric cancer
arm group label: Gastric dysplasia
arm group label: High-risk gastric lesions
arm group label: Normal and low-risk gastric lesions
intervention type: Procedure
intervention name: Colonoscopy with biopsies
description: Colonoscopy with proper biopsy or polypectomy material work-up will be used for identification and stratification of colorectal lesions as well as acquisition of biopsies for microbiota testing
arm group label: Colorectal cancer
arm group label: Colorectal high-risk lesions
arm group label: Colorectal low-risk adenoma
arm group label: Group of control (colorectal)
intervention type: Procedure
intervention name: Whole blood/ Plasma / serum sampling
description: Whole blood/Plasma/serum sampling will be used to obtain information for group stratification
arm group label: Active Tuberculosis
arm group label: Average risk general population
arm group label: Chronic liver disease
arm group label: Chronic pancreatitis
arm group label: Colorectal cancer
arm group label: Colorectal high-risk lesions
arm group label: Colorectal low-risk adenoma
arm group label: Gastric cancer
arm group label: Gastric dysplasia
arm group label: Group of Control (Tuberculosis)
arm group label: Group of control (colorectal)
arm group label: High-risk gastric lesions
arm group label: Liver cancer
arm group label: Normal and low-risk gastric lesions
arm group label: Oncological diseases of other locations
arm group label: Pancreatic cancer
arm group label: Upper respiratory tract acute infections
intervention type: Diagnostic Test
intervention name: Faecal sampling
description: Facal samples will be obtained for faecal occult blood testing as well as microbiota analysis
arm group label: Average risk general population
arm group label: Colorectal cancer
arm group label: Colorectal high-risk lesions
arm group label: Colorectal low-risk adenoma
arm group label: Gastric cancer
arm group label: Gastric dysplasia
arm group label: Group of control (colorectal)
arm group label: High-risk gastric lesions
arm group label: Normal and low-risk gastric lesions
intervention type: Procedure
intervention name: Histological examination of surgical specimen
description: Routine histological exam for patients undergoing curative or palliative surgery. Indication for surgery are set based on underlying condition. Study does not interfere with decision making for surgical treatment
arm group label: Colorectal cancer
arm group label: Colorectal high-risk lesions
arm group label: Colorectal low-risk adenoma
arm group label: Gastric cancer
arm group label: Gastric dysplasia
arm group label: High-risk gastric lesions
arm group label: Liver cancer
arm group label: Oncological diseases of other locations
arm group label: Pancreatic cancer
intervention type: Diagnostic Test
intervention name: Headspace analysis for biological material
description: VOC analysis from headspace of surgical specimen, biopsy materials, blood/plasma, microbiota etc.
arm group label: Active Tuberculosis
arm group label: Average risk general population
arm group label: Chronic liver disease
arm group label: Chronic pancreatitis
arm group label: Colorectal cancer
arm group label: Colorectal high-risk lesions
arm group label: Colorectal low-risk adenoma
arm group label: Gastric cancer
arm group label: Gastric dysplasia
arm group label: Group of Control (Tuberculosis)
arm group label: Group of control (colorectal)
arm group label: High-risk gastric lesions
arm group label: Liver cancer
arm group label: Normal and low-risk gastric lesions
arm group label: Oncological diseases of other locations
arm group label: Pancreatic cancer
arm group label: Upper respiratory tract acute infections
Surgery and biopsy material as well as blood samples will contain himan DNA
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mārcis Leja, PhD, MD
role: Study Director
affiliation: University of Latvia
last name: Lelde Lauka, MD
role: Principal Investigator
affiliation: University of Latvia
last name: Andra Cīrule, MD
role: Principal Investigator
affiliation: Riga East University Hospital
facility: 
country: Latvia
citation: Nakhleh MK, Amal H, Jeries R, Broza YY, Aboud M, Gharra A, Ivgi H, Khatib S, Badarneh S, Har-Shai L, Glass-Marmor L, Lejbkowicz I, Miller A, Badarny S, Winer R, Finberg J, Cohen-Kaminsky S, Perros F, Montani D, Girerd B, Garcia G, Simonneau G, Nakhoul F, Baram S, Salim R, Hakim M, Gruber M, Ronen O, Marshak T, Doweck I, Nativ O, Bahouth Z, Shi DY, Zhang W, Hua QL, Pan YY, Tao L, Liu H, Karban A, Koifman E, Rainis T, Skapars R, Sivins A, Ancans G, Liepniece-Karele I, Kikuste I, Lasina I, Tolmanis I, Johnson D, Millstone SZ, Fulton J, Wells JW, Wilf LH, Humbert M, Leja M, Peled N, Haick H. Diagnosis and Classification of 17 Diseases from 1404 Subjects via Pattern Analysis of Exhaled Molecules. ACS Nano. 2017 Jan 24;11(1):112-125. doi: 10.1021/acsnano.6b04930. Epub 2016 Dec 21.
PMID: 28000444
citation: Xu ZQ, Broza YY, Ionsecu R, Tisch U, Ding L, Liu H, Song Q, Pan YY, Xiong FX, Gu KS, Sun GP, Chen ZD, Leja M, Haick H. A nanomaterial-based breath test for distinguishing gastric cancer from benign gastric conditions. Br J Cancer. 2013 Mar 5;108(4):941-50. doi: 10.1038/bjc.2013.44.
PMID: 23462808
citation: Amal H, Leja M, Broza YY, Tisch U, Funka K, Liepniece-Karele I, Skapars R, Xu ZQ, Liu H, Haick H. Geographical variation in the exhaled volatile organic compounds. J Breath Res. 2013 Dec;7(4):047102. doi: 10.1088/1752-7155/7/4/047102. Epub 2013 Nov 1.
PMID: 24184568
responsible party type: Sponsor
mesh term: Tuberculosis
mesh term: Communicable Diseases
mesh term: Infections
mesh term: Influenza, Human
mesh term: Adenoma
mesh term: Inflammatory Bowel Diseases
mesh term: Pancreatitis
mesh term: Liver Cirrhosis
mesh term: Gastritis
mesh term: Peptic Ulcer
mesh term: Gastritis, Atrophic
mesh term: Pancreatitis, Chronic
mesh term: Metaplasia