<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/NCT03303222</url>
  </required_header>
  <id_info>
    <org_study_id>IRAS 228416</org_study_id>
    <nct_id>NCT03303222</nct_id>
  </id_info>
  <brief_title>Study to Develop a Breath Analyser to Detect Chronic Kidney Disease</brief_title>
  <official_title>Pilot Study to Develop a Breath Analyser to Detect Chronic Kidney Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University College, London</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>
      Measure trimethylamine oxide in the breath.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Organic compounds such as trimethylamine oxide (TMAO) accumulate in the blood of patients&#xD;
      with kidney disease, and volatile compounds such as TMAO can be detected in the breath.&#xD;
&#xD;
      The investigators wish to develop a breath analyser to measure volatile compounds, such as&#xD;
      TMAO in the breath in patients with kidney disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">February 10, 2021</start_date>
  <completion_date type="Anticipated">November 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2023</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>measurement of breath TMAO</measure>
    <time_frame>3 years</time_frame>
    <description>measurement of breath TMAO by breath analyser</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Kidney Diseases</condition>
  <arm_group>
    <arm_group_label>patients on dialysis</arm_group_label>
    <description>patients with kidney disease treated by dialysis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>patients with chronic kidney disease</arm_group_label>
    <description>patients with chronic kidney disease not treated by dialysis</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>breath</intervention_name>
    <description>measurement of volatile compounds, such as TMAO in exhaled breath and blood</description>
    <arm_group_label>patients on dialysis</arm_group_label>
    <arm_group_label>patients with chronic kidney disease</arm_group_label>
    <other_name>blood sample</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with kidney disease under the care of Royal Free Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with kidney disease under the care of Royal Free Hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients unable to provide informed consent&#xD;
&#xD;
          -  patients unable to exhale into breath analyser&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>andrew davenport, md</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCL, London</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>andrew davenport, md</last_name>
    <phone>442077940500</phone>
    <email>andrewdavenport@nhs.net</email>
  </overall_contact>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>November 3, 2020</last_update_submitted>
  <last_update_submitted_qc>November 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data will be filed in UCL library as PhD submission</ipd_description>
  </patient_data>
  <!-- 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/NCT03303222
org study id: IRAS 228416
nct id: NCT03303222
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Measure trimethylamine oxide in the breath.
Organic compounds such as trimethylamine oxide (TMAO) accumulate in the blood of patients
      with kidney disease, and volatile compounds such as TMAO can be detected in the breath.

      The investigators wish to develop a breath analyser to measure volatile compounds, such as
      TMAO in the breath in patients with kidney disease.
observational model: Cohort
time perspective: Prospective
measure: measurement of breath TMAO
time frame: 3 years
description: measurement of breath TMAO by breath analyser
arm group label: patients on dialysis
description: patients with kidney disease treated by dialysis
arm group label: patients with chronic kidney disease
description: patients with chronic kidney disease not treated by dialysis
intervention type: Diagnostic Test
intervention name: breath
description: measurement of volatile compounds, such as TMAO in exhaled breath and blood
arm group label: patients on dialysis
arm group label: patients with chronic kidney disease
other name: blood sample
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: andrew davenport, md
role: Principal Investigator
affiliation: UCL, London
last name: andrew davenport, md
phone: 442077940500
email: andrewdavenport@nhs.net
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
sharing ipd: No
ipd description: Data will be filed in UCL library as PhD submission