xml: <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/NCT06020521</url>
    </required_header>
    <id_info>
      <org_study_id>2023_0020</org_study_id>
      <nct_id>NCT06020521</nct_id>
    </id_info>
    <brief_title>Analysis of Volatile Organic Compounds in Expired Air in Healthy Volunteers: Comparison of Three Mass Spectrometry Techniques for the Characterization of Volatolome in Clinical Studies</brief_title>
    <acronym>VOC-COMPARE</acronym>
    <official_title>Analysis of Volatile Organic Compounds in Expired Air in Healthy Volunteers: Comparison of Three Mass Spectrometry Techniques for the Characterization of Volatolome in Clinical Studies</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hopital Foch</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hopital Foch</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>
        A major obstacle in precision medicine is the unavailability of biomarkers that are easy to&#xD;
        access, non-invasive, measurable with high-performance techniques, fast, easy to use,&#xD;
        reproducible, inexpensive and easily deployable on a large scale. The analysis of exhaled air&#xD;
        (volatolomics) is an &quot;omics&quot; approach devoted to the analysis of volatile organic compounds&#xD;
        (VOCs) eliminated by the pulmonary route with real-time detection, at the patient's bedside.&#xD;
        The reference technology for the analysis of VOCs is mass spectrometry (MS). Several types of&#xD;
        mass spectrometers can be used, and, in the absence of a consensual and standardized method,&#xD;
        have practical methods for carrying out different analyzes which also lead to the generation&#xD;
        of specific signals whose nature, complexity and exhaustiveness of information generated are&#xD;
        heterogeneous. The clinical studies carried out to date use one of the analytical techniques&#xD;
        available, without the choice necessarily being guided by objective factors. The objective of&#xD;
        this study is to fill this gap and compare the information obtained by three mass&#xD;
        spectrometry techniques available to our team (proton transfer reaction - mass spectrometry&#xD;
        (PTR-MS), Soft Ionization by Chemical Reaction in Transfer (SICRIT) , two-dimensional gas&#xD;
        chromatography-mass spectrometry (GCxGC-MS)) for volatolome analysis. The comparative&#xD;
        analysis of the different signals will make it possible to determine the interests and limits&#xD;
        of each technique and thus to direct preferentially towards one, the other, or combinations&#xD;
        of them for the realization of future clinical studies. One of the main challenges also&#xD;
        consists in establishing the concordance of the signals generated by the different&#xD;
        technological approaches, some employing prior chromatographic separation, others not, and&#xD;
        some employing soft ionization methods while those of others are on the contrary hard. Thus,&#xD;
        the availability of datasets obtained on the same population with these complementary&#xD;
        approaches will allow significant progress for the identification of the COVs of interest in&#xD;
        clinical studies, beyond the simple comparison of the analytical performances of the&#xD;
        different methods.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Precision medicine, or personalized medicine or individualized medicine, represents an&#xD;
        important source of hope for alleviating the social and economic burden of severe&#xD;
        pathologies. There is no commonly accepted definition of the notion of &quot;personalized&#xD;
        medicine&quot;. However, according to the European Council, personalized medicine is a medical&#xD;
        model that relies on the characterization of people's phenotypes and genotypes (e.g. through&#xD;
        molecular profiling, medical imaging, lifestyle information) to offer the right therapeutic&#xD;
        strategy to the right person at the right time and/or to establish the existence of a&#xD;
        predisposition to a disease and/or to ensure targeted and timely prevention. Personalized&#xD;
        medicine is linked to the broader notion of &quot;patient-centred care&quot;, which takes into account&#xD;
        the general need for health systems to better meet the needs of patients. Advances in&#xD;
        research have made it possible to develop &quot;omic&quot; signatures of therapeutic responses to&#xD;
        certain cancers or rare diseases. However, if a few omic or cellular biomarkers have been&#xD;
        developed, they remain today insufficient and too complex to foresee their generalization for&#xD;
        the individualized treatment of patients. Thus, today there is significant potential for the&#xD;
        development of precision medicine for severe pathologies. A major obstacle in precision&#xD;
        medicine is the unavailability of biomarkers that are easy to access, non-invasive,&#xD;
        measurable with high-performance techniques, fast, easy to use, reproducible, inexpensive and&#xD;
        easily deployable on a large scale.&#xD;
  &#xD;
        The analysis of exhaled air (volatolomics) is derived from the latest &quot;omics&quot; technology,&#xD;
        metabolomics, devoted to the analysis of small molecules in the body, and allows real-time&#xD;
        detection, sick bed, volatile organic compounds (VOCs) eliminated through the lungs.&#xD;
        Thousands of VOCs have been identified in exhaled air following infectious, inflammatory or&#xD;
        pathological events with examples in the field of infectious diseases for the diagnosis of&#xD;
        tuberculosis, invasive fungal infections, bacterial colonization of the airways or&#xD;
        ventilator-associated pneumonia in intensive care patients . For viral infections, animal&#xD;
        models of influenza infections and clinical studies in patients with chronic obstructive&#xD;
        pulmonary disease also suggest the benefit of VOC analysis . In this infectious context, the&#xD;
        &quot;respiratory fingerprint&quot; detected reflects a mixture of metabolites of microbial origin,&#xD;
        direct biomarkers of the presence of pathogenic agents, and metabolites generated by the host&#xD;
        in response to the infection. Thus, the analysis of exhaled air, the main advantages of which&#xD;
        are totally non-invasive sampling and the instantaneous analysis allowed by certain&#xD;
        technologies (result in a few minutes) could be used for diagnosis, large-scale screening,&#xD;
        surveillance of infections and prediction of response to treatment. The technological&#xD;
        challenges for its realization are linked to the great chemical diversity of the VOCs to be&#xD;
        studied and the particularly low abundance of many of them.&#xD;
  &#xD;
        The reference technology for the analysis of VOCs is mass spectrometry (MS), which uses&#xD;
        instruments consisting of - an ionization source whose function is to ionize the VOCs&#xD;
        contained in exhaled air, - an analyzer which sorts the ions formed according to their mass&#xD;
        to charge ratio (m/z) and - a detector which allows the quantitative analysis of the m/z&#xD;
        signals of a sample . Several types of mass spectrometers can be used, and, in the absence of&#xD;
        a consensual and standardized method, have practical methods for carrying out different&#xD;
        analyzes which also lead to the generation of signals specific to each of them, the nature,&#xD;
        the complexity and the completeness of the information contained being heterogeneous. Each&#xD;
        type of instrument has advantages and disadvantages in terms of ease of sampling, speed of&#xD;
        analysis, completeness of information and technical and analytical constraints for carrying&#xD;
        out the analyses. For example, some instruments such as proton transfer reaction mass&#xD;
        spectrometers (PTR-MS) or those using soft ionization by chemical transfer reaction (SICRIT)&#xD;
        are relevant for perform measurements online and in real time, without storing a sample of&#xD;
        exhaled air but vary by their mode of ionization and the resolution of the associated&#xD;
        detectors. However, their level of information generated does not generally allow VOCs to be&#xD;
        identified (soft ionization, absence of chromatographic separation, etc.). Indeed, once a&#xD;
        signature of VOCs (characterized by their m/z) is discovered, their formal chemical&#xD;
        identification is then the critical and obligatory step to improve knowledge on the&#xD;
        physiology and regulatory processes of VOCs as well as to set up and clinically validate&#xD;
        specific quantitative measurement methods based on portable technologies (sensors, etc.).&#xD;
        Two-dimensional gas chromatography coupled with mass spectrometry (GCxGC-MS) is the most&#xD;
        advanced technology at present for this purpose, combining two chromatographic columns with&#xD;
        complementary stationary phases and ionization of VOCs by electron impact before MS&#xD;
        detection. Compounds coeluting in conventional gas chromatography can be separated by GCxGC,&#xD;
        and several teams have published proof-of-concept studies using GCxGC-MS for breath biomarker&#xD;
        discovery for lung cancer diagnosis , tuberculosis or severe asthma phenotyping . One of the&#xD;
        main challenges consists in establishing the concordance of the signals generated by the&#xD;
        different technological approaches, some employing a preliminary chromatographic separation,&#xD;
        others not, and some employing soft ionization methods whereas those of the others are on the&#xD;
        contrary hard. Thus, the availability of datasets obtained on the same population with these&#xD;
        complementary technological approaches will allow significant progress for the identification&#xD;
        of the COVs of interest in clinical studies, beyond the simple comparison of the analytical&#xD;
        performances of the different methods.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 8, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>This research will take place at the hospital and at the UFR Simone Veil-Santé with single sessions on the same day of approximately 10 minutes and 1 hour respectively. A list of healthy volunteers has already been established at the faculty. A provisional schedule for passing the various examinations provided for in the protocol is also scheduled. The experiments conducted at the UFR Simone Veil - Santé will take place within the Department of Health Biotechnology. This Department already has all the resources necessary for the successful completion of the study, in particular within the mass spectrometry platform which has the instruments (high resolution mass spectrometer Q-Exactive) and human resources (2 analytical science engineers, 1 data science engineer + technical staff and interns) required.</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>To compare informations obtained by three different spectrometry techniques</measure>
      <time_frame>one day</time_frame>
      <description>Compare the information obtained by three mass spectrometry techniques (PTR-MS, SICRIT, GCxGC-MS) for the analysis of volatolome during clinical studies</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>1- Compare sampling techniques</measure>
      <time_frame>one day</time_frame>
      <description>Compare the information obtained by three mass spectrometry techniques (PTR-MS, SICRIT, GCxGC-MS) for the analysis of volatolome during clinical studies</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>2-Compare the profile of VOCs</measure>
      <time_frame>one day</time_frame>
      <description>Compare the profile of VOCs of differents patients</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Determine the average time needed to perform each type of sample and associated analyzes</measure>
      <time_frame>one day</time_frame>
      <description>Determine the average time needed to perform each type of sample and associated analyzes</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Respiratory Disease</condition>
    <arm_group>
      <arm_group_label>Group of healthy volunteers</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>This research will take place at the hospital and at the UFR Simone Veil-Santé with single sessions on the same day of approximately 10 minutes and 1 hour respectively. A list of healthy volunteers has already been established at the faculty. A provisional schedule for passing the various examinations provided for in the protocol is also scheduled. The experiments conducted at the UFR Simone Veil - Santé will take place within the Department of Health Biotechnology. This Department already has all the resources necessary for the successful completion of the study, in particular within the mass spectrometry platform which has the instruments (high resolution mass spectrometer Q-Exactive) and human resources (2 analytical science engineers, 1 data science engineer + technical staff and interns) required.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Three spectrometry differents technics</intervention_name>
      <description>Collection of expired air as follows:&#xD;
  For online mass spectrometry techniques (PTR-MS and SICRIT)&#xD;
  For offline mass spectrometry (GCxGC-MS)&#xD;
  Performing volatolome analyses:&#xD;
  By PTR-TOF-MS (Ionicon) and SICRIT-HRMS (SICRIT module (Plasmion) coupled to a Q-exactive instrument (Thermofisher)) for online analyzes&#xD;
  By two-dimensional gas chromatography coupled with mass spectrometry (Pegasus BT-4D, Leco) for the desorption tubes.</description>
      <arm_group_label>Group of healthy volunteers</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Healthy volunteer&#xD;
  &#xD;
            -  At least 18 years old&#xD;
  &#xD;
            -  Perfect command of the French language&#xD;
  &#xD;
            -  Signature of an informed consent form&#xD;
  &#xD;
            -  Affiliated to a health insurance plan&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant women&#xD;
  &#xD;
            -  People with known pathology(ies)&#xD;
  &#xD;
            -  Active smoking&#xD;
  &#xD;
            -  Deprived of liberty or under guardianship&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Stanislas Grassin delyle, PR</last_name>
      <phone>01 46 25 73 93</phone>
      <email>s.grassindelyle@hopital-foch.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>DRCI promotion</last_name>
      <phone>01 46 25 36 42</phone>
      <email>drci-promotion@hopital-foch.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Grassin delyle</name>
        <address>
          <city>Suresnes</city>
          <zip>92150</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Stanislas Grassin delyle, PR</last_name>
        <phone>04 46 25 73 93</phone>
        <email>s.grassindelyle@hopital-foch.com</email>
      </contact>
      <contact_backup>
        <last_name>DRCI PROMOTION</last_name>
        <phone>01 46 25 36 42</phone>
        <email>drci-promotion@hopital-foch.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>precision medicine,</keyword>
    <keyword>biomarkers</keyword>
    <keyword>analysis of exhaled air (volatolomics)</keyword>
    <keyword>mass spectrometry</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Respiratory Tract Diseases</mesh_term>
      <mesh_term>Respiration Disorders</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06020521
  org study id: 2023_0020
  nct id: NCT06020521
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  A major obstacle in precision medicine is the unavailability of biomarkers that are easy to
        access, non-invasive, measurable with high-performance techniques, fast, easy to use,
        reproducible, inexpensive and easily deployable on a large scale. The analysis of exhaled air
        (volatolomics) is an "omics" approach devoted to the analysis of volatile organic compounds
        (VOCs) eliminated by the pulmonary route with real-time detection, at the patient's bedside.
        The reference technology for the analysis of VOCs is mass spectrometry (MS). Several types of
        mass spectrometers can be used, and, in the absence of a consensual and standardized method,
        have practical methods for carrying out different analyzes which also lead to the generation
        of specific signals whose nature, complexity and exhaustiveness of information generated are
        heterogeneous. The clinical studies carried out to date use one of the analytical techniques
        available, without the choice necessarily being guided by objective factors. The objective of
        this study is to fill this gap and compare the information obtained by three mass
        spectrometry techniques available to our team (proton transfer reaction - mass spectrometry
        (PTR-MS), Soft Ionization by Chemical Reaction in Transfer (SICRIT) , two-dimensional gas
        chromatography-mass spectrometry (GCxGC-MS)) for volatolome analysis. The comparative
        analysis of the different signals will make it possible to determine the interests and limits
        of each technique and thus to direct preferentially towards one, the other, or combinations
        of them for the realization of future clinical studies. One of the main challenges also
        consists in establishing the concordance of the signals generated by the different
        technological approaches, some employing prior chromatographic separation, others not, and
        some employing soft ionization methods while those of others are on the contrary hard. Thus,
        the availability of datasets obtained on the same population with these complementary
        approaches will allow significant progress for the identification of the COVs of interest in
        clinical studies, beyond the simple comparison of the analytical performances of the
        different methods.
  Precision medicine, or personalized medicine or individualized medicine, represents an
        important source of hope for alleviating the social and economic burden of severe
        pathologies. There is no commonly accepted definition of the notion of "personalized
        medicine". However, according to the European Council, personalized medicine is a medical
        model that relies on the characterization of people's phenotypes and genotypes (e.g. through
        molecular profiling, medical imaging, lifestyle information) to offer the right therapeutic
        strategy to the right person at the right time and/or to establish the existence of a
        predisposition to a disease and/or to ensure targeted and timely prevention. Personalized
        medicine is linked to the broader notion of "patient-centred care", which takes into account
        the general need for health systems to better meet the needs of patients. Advances in
        research have made it possible to develop "omic" signatures of therapeutic responses to
        certain cancers or rare diseases. However, if a few omic or cellular biomarkers have been
        developed, they remain today insufficient and too complex to foresee their generalization for
        the individualized treatment of patients. Thus, today there is significant potential for the
        development of precision medicine for severe pathologies. A major obstacle in precision
        medicine is the unavailability of biomarkers that are easy to access, non-invasive,
        measurable with high-performance techniques, fast, easy to use, reproducible, inexpensive and
        easily deployable on a large scale.
  
        The analysis of exhaled air (volatolomics) is derived from the latest "omics" technology,
        metabolomics, devoted to the analysis of small molecules in the body, and allows real-time
        detection, sick bed, volatile organic compounds (VOCs) eliminated through the lungs.
        Thousands of VOCs have been identified in exhaled air following infectious, inflammatory or
        pathological events with examples in the field of infectious diseases for the diagnosis of
        tuberculosis, invasive fungal infections, bacterial colonization of the airways or
        ventilator-associated pneumonia in intensive care patients . For viral infections, animal
        models of influenza infections and clinical studies in patients with chronic obstructive
        pulmonary disease also suggest the benefit of VOC analysis . In this infectious context, the
        "respiratory fingerprint" detected reflects a mixture of metabolites of microbial origin,
        direct biomarkers of the presence of pathogenic agents, and metabolites generated by the host
        in response to the infection. Thus, the analysis of exhaled air, the main advantages of which
        are totally non-invasive sampling and the instantaneous analysis allowed by certain
        technologies (result in a few minutes) could be used for diagnosis, large-scale screening,
        surveillance of infections and prediction of response to treatment. The technological
        challenges for its realization are linked to the great chemical diversity of the VOCs to be
        studied and the particularly low abundance of many of them.
  
        The reference technology for the analysis of VOCs is mass spectrometry (MS), which uses
        instruments consisting of - an ionization source whose function is to ionize the VOCs
        contained in exhaled air, - an analyzer which sorts the ions formed according to their mass
        to charge ratio (m/z) and - a detector which allows the quantitative analysis of the m/z
        signals of a sample . Several types of mass spectrometers can be used, and, in the absence of
        a consensual and standardized method, have practical methods for carrying out different
        analyzes which also lead to the generation of signals specific to each of them, the nature,
        the complexity and the completeness of the information contained being heterogeneous. Each
        type of instrument has advantages and disadvantages in terms of ease of sampling, speed of
        analysis, completeness of information and technical and analytical constraints for carrying
        out the analyses. For example, some instruments such as proton transfer reaction mass
        spectrometers (PTR-MS) or those using soft ionization by chemical transfer reaction (SICRIT)
        are relevant for perform measurements online and in real time, without storing a sample of
        exhaled air but vary by their mode of ionization and the resolution of the associated
        detectors. However, their level of information generated does not generally allow VOCs to be
        identified (soft ionization, absence of chromatographic separation, etc.). Indeed, once a
        signature of VOCs (characterized by their m/z) is discovered, their formal chemical
        identification is then the critical and obligatory step to improve knowledge on the
        physiology and regulatory processes of VOCs as well as to set up and clinically validate
        specific quantitative measurement methods based on portable technologies (sensors, etc.).
        Two-dimensional gas chromatography coupled with mass spectrometry (GCxGC-MS) is the most
        advanced technology at present for this purpose, combining two chromatographic columns with
        complementary stationary phases and ionization of VOCs by electron impact before MS
        detection. Compounds coeluting in conventional gas chromatography can be separated by GCxGC,
        and several teams have published proof-of-concept studies using GCxGC-MS for breath biomarker
        discovery for lung cancer diagnosis , tuberculosis or severe asthma phenotyping . One of the
        main challenges consists in establishing the concordance of the signals generated by the
        different technological approaches, some employing a preliminary chromatographic separation,
        others not, and some employing soft ionization methods whereas those of the others are on the
        contrary hard. Thus, the availability of datasets obtained on the same population with these
        complementary technological approaches will allow significant progress for the identification
        of the COVs of interest in clinical studies, beyond the simple comparison of the analytical
        performances of the different methods.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: This research will take place at the hospital and at the UFR Simone Veil-Santé with single sessions on the same day of approximately 10 minutes and 1 hour respectively. A list of healthy volunteers has already been established at the faculty. A provisional schedule for passing the various examinations provided for in the protocol is also scheduled. The experiments conducted at the UFR Simone Veil - Santé will take place within the Department of Health Biotechnology. This Department already has all the resources necessary for the successful completion of the study, in particular within the mass spectrometry platform which has the instruments (high resolution mass spectrometer Q-Exactive) and human resources (2 analytical science engineers, 1 data science engineer + technical staff and interns) required.
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: To compare informations obtained by three different spectrometry techniques
  time frame: one day
  description: Compare the information obtained by three mass spectrometry techniques (PTR-MS, SICRIT, GCxGC-MS) for the analysis of volatolome during clinical studies
  measure: 1- Compare sampling techniques
  time frame: one day
  description: Compare the information obtained by three mass spectrometry techniques (PTR-MS, SICRIT, GCxGC-MS) for the analysis of volatolome during clinical studies
  measure: 2-Compare the profile of VOCs
  time frame: one day
  description: Compare the profile of VOCs of differents patients
  measure: Determine the average time needed to perform each type of sample and associated analyzes
  time frame: one day
  description: Determine the average time needed to perform each type of sample and associated analyzes
  arm group label: Group of healthy volunteers
  arm group type: Other
  description: This research will take place at the hospital and at the UFR Simone Veil-Santé with single sessions on the same day of approximately 10 minutes and 1 hour respectively. A list of healthy volunteers has already been established at the faculty. A provisional schedule for passing the various examinations provided for in the protocol is also scheduled. The experiments conducted at the UFR Simone Veil - Santé will take place within the Department of Health Biotechnology. This Department already has all the resources necessary for the successful completion of the study, in particular within the mass spectrometry platform which has the instruments (high resolution mass spectrometer Q-Exactive) and human resources (2 analytical science engineers, 1 data science engineer + technical staff and interns) required.
  intervention type: Other
  intervention name: Three spectrometry differents technics
  description: Collection of expired air as follows:
  For online mass spectrometry techniques (PTR-MS and SICRIT)
  For offline mass spectrometry (GCxGC-MS)
  Performing volatolome analyses:
  By PTR-TOF-MS (Ionicon) and SICRIT-HRMS (SICRIT module (Plasmion) coupled to a Q-exactive instrument (Thermofisher)) for online analyzes
  By two-dimensional gas chromatography coupled with mass spectrometry (Pegasus BT-4D, Leco) for the desorption tubes.
  arm group label: Group of healthy volunteers
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Stanislas Grassin delyle, PR
  phone: 01 46 25 73 93
  email: s.grassindelyle@hopital-foch.com
  last name: DRCI promotion
  phone: 01 46 25 36 42
  email: drci-promotion@hopital-foch.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: France
  responsible party type: Sponsor
  mesh term: Respiratory Tract Diseases
  mesh term: Respiration Disorders