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/NCT05998109</url>
    </required_header>
    <id_info>
      <org_study_id>CLR-0012</org_study_id>
      <nct_id>NCT05998109</nct_id>
    </id_info>
    <brief_title>PheCheck Feasibility Study</brief_title>
    <official_title>PheCheck Feasibility Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Lumos Diagnostics</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Aptatek Biosciences</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Lumos Diagnostics</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this feasibility study clinical trial is to compare the accuracy of PheCheck™ for&#xD;
        the rapid quantitative detection of phenylalanine (Phe) with the gold standard (HPLC amino&#xD;
        acid analyzer), in patients with PKU.&#xD;
  &#xD;
        The main aims are:&#xD;
  &#xD;
          -  Evaluate the accuracy of PheCheck as compared to the gold standard&#xD;
  &#xD;
          -  Evaluate ease of use by lay participants&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The primary objective of this feasibility study is to evaluate the accuracy of the analyte&#xD;
        concentration of PheCheck™ for the rapid, quantitative detection of phenylalanine (Phe) from&#xD;
        capillary blood compared to the gold standard (HPLC amino acid analyzer) which quantitatively&#xD;
        measures Phe in venous blood.&#xD;
  &#xD;
        The study will enroll subjects into one study cohort. It will include patients 10 years or&#xD;
        older, monitored for Phenylketonuria (PKU), hyperphenylalaninemia or PKU during pregnancy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 17, 2023</start_date>
    <completion_date type="Anticipated">October 19, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 28, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Concentration of phenylalanine (Phe) from PheCheck as compared to HPLC amino acid analyzer</measure>
      <time_frame>6-8 weeks</time_frame>
      <description>The primary outcome is the concentration of phenylalanine (Phe) from capillary blood as compared to the gold standard HPLC amino acid analyzer</description>
    </primary_outcome>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Phenylketonurias</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>PheCheck™</intervention_name>
      <description>1 fingerstick specimen collected at each study visit</description>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>HPLC Amino Acid Analyzer</intervention_name>
      <description>1 venous specimen collected at each study visit</description>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Dried Blood Spot Cards</intervention_name>
      <description>capillary blood specimen collected at each study visit</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients ≥ 10 years who are undergoing monitoring for Phenylketonuria (PKU)&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  10 years of age or older&#xD;
  &#xD;
            -  Being monitored for Phenylketonuria (PKU), hyperphenylalaninemia or for PKU during&#xD;
               pregnancy Signed informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Younger than 10 years of age&#xD;
  &#xD;
            -  Not being monitored for Phenylketonuria (PKU), hyperphenylalaninemia or for PKU during&#xD;
               pregnancy&#xD;
  &#xD;
            -  Lack of signed informed consent&#xD;
  &#xD;
            -  Previous enrollment in the study and has completed study visit 1 and 2&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>10 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Annie Bell, MSN, APN</last_name>
      <phone>7737298954</phone>
      <email>annie.bell@lumosdiagnostics.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Catalina Suarez-Cuervo, MD</last_name>
      <phone>7277765880</phone>
      <email>Catalina.Suarez@lumosdiagnostics.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>UPMC Children's Hospital of Pittsburgh</name>
        <address>
          <city>Pittsburgh</city>
          <state>Pennsylvania</state>
          <zip>15224</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Gerard Vockley, MD</last_name>
        <email>vockleyg@upmc.edu</email>
      </contact>
      <contact_backup>
        <last_name>Jennifer Baker, MA</last_name>
        <phone>4126926378</phone>
        <email>Jennifer.Baker@chp.edu</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</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>Phenylketonurias</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05998109
  org study id: CLR-0012
  nct id: NCT05998109
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this feasibility study clinical trial is to compare the accuracy of PheCheck™ for
        the rapid quantitative detection of phenylalanine (Phe) with the gold standard (HPLC amino
        acid analyzer), in patients with PKU.
  
        The main aims are:
  
          -  Evaluate the accuracy of PheCheck as compared to the gold standard
  
          -  Evaluate ease of use by lay participants
  The primary objective of this feasibility study is to evaluate the accuracy of the analyte
        concentration of PheCheck™ for the rapid, quantitative detection of phenylalanine (Phe) from
        capillary blood compared to the gold standard (HPLC amino acid analyzer) which quantitatively
        measures Phe in venous blood.
  
        The study will enroll subjects into one study cohort. It will include patients 10 years or
        older, monitored for Phenylketonuria (PKU), hyperphenylalaninemia or PKU during pregnancy.
  observational model: Other
  time perspective: Prospective
  measure: Concentration of phenylalanine (Phe) from PheCheck as compared to HPLC amino acid analyzer
  time frame: 6-8 weeks
  description: The primary outcome is the concentration of phenylalanine (Phe) from capillary blood as compared to the gold standard HPLC amino acid analyzer
  intervention type: Device
  intervention name: PheCheck™
  description: 1 fingerstick specimen collected at each study visit
  intervention type: Diagnostic Test
  intervention name: HPLC Amino Acid Analyzer
  description: 1 venous specimen collected at each study visit
  intervention type: Diagnostic Test
  intervention name: Dried Blood Spot Cards
  description: capillary blood specimen collected at each study visit
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 10 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Annie Bell, MSN, APN
  phone: 7737298954
  email: annie.bell@lumosdiagnostics.com
  last name: Catalina Suarez-Cuervo, MD
  phone: 7277765880
  email: Catalina.Suarez@lumosdiagnostics.com
  facility: 
  contact: 
  contact backup: 
  country: United States
  responsible party type: Sponsor
  mesh term: Phenylketonurias
  sharing ipd: Undecided