<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/NCT03231865</url>
  </required_header>
  <id_info>
    <org_study_id>2017-00054</org_study_id>
    <nct_id>NCT03231865</nct_id>
  </id_info>
  <brief_title>Diagnostic of Iron Deficiency by Means of Non Invasive Measurement of Zink Protoporphyrin IX</brief_title>
  <acronym>ZnPP</acronym>
  <official_title>Diagnostic of Iron Deficiency by Means of Non Invasive Measurement of Zink Protoporphyrin IX</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Philipp Stein</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</source>
  <oversight_info>
    <has_dmc>Yes</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>
      ZnPP is being build in the case of a functional iron deficiency. Zinc instead of iron is&#xD;
      implemented into protoporphyrin IX. This ZincProtoporphyrin (ZnPP) can be detected non&#xD;
      invasively. Non invasive and invasive optical measurement of ZnPP will be compared.&#xD;
      Additionally ZnPP measurements will be compared to other iron deficiency parameters for&#xD;
      validation by the investigators.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Zinc-protoporphyrin (ZnPP) will be measured by a fluorescence technique. Restricted wave&#xD;
      light (407/425 nm) is used to detect ZnPP in the bloodstream non-invasively through the oral&#xD;
      mucosa. The spectroscopic measurements are translated into a ZnPP value (mumol/mol heme).&#xD;
&#xD;
      The non-invasive measurement of ZnPP is validated and compared to optical measurement of ZnPP&#xD;
      in whole blood and high performance liquid chromatography (HPLC) measurement of ZnPP in whole&#xD;
      blood.&#xD;
&#xD;
      The ZnPP value is compared to other iron-deficiency parameters: Ferritin, Transferrin&#xD;
      saturation and soluble Transferrin receptor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 27, 2017</start_date>
  <completion_date type="Actual">May 31, 2018</completion_date>
  <primary_completion_date type="Actual">February 26, 2018</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>Validation of the non-invasive ZincProtoporphyrinIX measurement</measure>
    <time_frame>Baseline</time_frame>
    <description>The value is compared to optical measurement of ZincProtoporphyrin in whole blood; in addition the value is compared to HPLC measurement in whole blood</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of the ZincProtoporyphyrinIX value to other iron-deficiency parameters</measure>
    <time_frame>Baseline</time_frame>
    <description>The value is compared to Ferritin, Transferrin saturation and soluble transferrin receptor</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">300</enrollment>
  <condition>Iron-deficiency</condition>
  <arm_group>
    <arm_group_label>Preoperative patients</arm_group_label>
    <description>Patients present themselves before an operation to the Anesthesiologist. They are screened for study eligibility.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Non-invasive measurement of ZincProtoporphyrin IX</intervention_name>
    <description>Within 30 seconds, a measurement is performed on the lip of a patient to determine a ZincProtoporphyrin value</description>
    <arm_group_label>Preoperative patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients prior to a surgery, seen in the Anesthetic clinic for evaluation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients seen preoperatively in the Anesthestic clinic&#xD;
&#xD;
          -  Patients &gt; 18 years of age&#xD;
&#xD;
          -  Understood and signed patient consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  transfusion of blood products 8 weeks prior to screening&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Porphyria&#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>Philipp Stein, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Anesthesiology, University and University Hospital Zurich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Zurich</name>
      <address>
        <city>Zurich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>Hennig G, Homann C, Teksan I, Hasbargen U, Hasmuller S, Holdt LM, Khaled N, Sroka R, Stauch T, Stepp H, Vogeser M, Brittenham GM. Non-invasive detection of iron deficiency by fluorescence measurement of erythrocyte zinc protoporphyrin in the lip. Nat Commun. 2016 Feb 17;7:10776. doi: 10.1038/ncomms10776.</citation>
    <PMID>26883939</PMID>
  </reference>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>June 7, 2018</last_update_submitted>
  <last_update_submitted_qc>June 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Zurich</investigator_affiliation>
    <investigator_full_name>Philipp Stein</investigator_full_name>
    <investigator_title>Dr. med Philipp Stein</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia, Iron-Deficiency</mesh_term>
    <mesh_term>Iron Deficiencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03231865
org study id: 2017-00054
nct id: NCT03231865
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
ZnPP is being build in the case of a functional iron deficiency. Zinc instead of iron is
      implemented into protoporphyrin IX. This ZincProtoporphyrin (ZnPP) can be detected non
      invasively. Non invasive and invasive optical measurement of ZnPP will be compared.
      Additionally ZnPP measurements will be compared to other iron deficiency parameters for
      validation by the investigators.
Zinc-protoporphyrin (ZnPP) will be measured by a fluorescence technique. Restricted wave
      light (407/425 nm) is used to detect ZnPP in the bloodstream non-invasively through the oral
      mucosa. The spectroscopic measurements are translated into a ZnPP value (mumol/mol heme).

      The non-invasive measurement of ZnPP is validated and compared to optical measurement of ZnPP
      in whole blood and high performance liquid chromatography (HPLC) measurement of ZnPP in whole
      blood.

      The ZnPP value is compared to other iron-deficiency parameters: Ferritin, Transferrin
      saturation and soluble Transferrin receptor.
observational model: Cohort
time perspective: Prospective
measure: Validation of the non-invasive ZincProtoporphyrinIX measurement
time frame: Baseline
description: The value is compared to optical measurement of ZincProtoporphyrin in whole blood; in addition the value is compared to HPLC measurement in whole blood
measure: Comparison of the ZincProtoporyphyrinIX value to other iron-deficiency parameters
time frame: Baseline
description: The value is compared to Ferritin, Transferrin saturation and soluble transferrin receptor
arm group label: Preoperative patients
description: Patients present themselves before an operation to the Anesthesiologist. They are screened for study eligibility.
intervention type: Diagnostic Test
intervention name: Non-invasive measurement of ZincProtoporphyrin IX
description: Within 30 seconds, a measurement is performed on the lip of a patient to determine a ZincProtoporphyrin value
arm group label: Preoperative patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Philipp Stein, MD
role: Principal Investigator
affiliation: Institute of Anesthesiology, University and University Hospital Zurich
facility: 
country: Switzerland
citation: Hennig G, Homann C, Teksan I, Hasbargen U, Hasmuller S, Holdt LM, Khaled N, Sroka R, Stauch T, Stepp H, Vogeser M, Brittenham GM. Non-invasive detection of iron deficiency by fluorescence measurement of erythrocyte zinc protoporphyrin in the lip. Nat Commun. 2016 Feb 17;7:10776. doi: 10.1038/ncomms10776.
PMID: 26883939
responsible party type: Sponsor-Investigator
investigator affiliation: University of Zurich
investigator full name: Philipp Stein
investigator title: Dr. med Philipp Stein
mesh term: Anemia, Iron-Deficiency
mesh term: Iron Deficiencies
sharing ipd: Undecided