<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/NCT04474132</url>
  </required_header>
  <id_info>
    <org_study_id>IRB20-0442</org_study_id>
    <nct_id>NCT04474132</nct_id>
  </id_info>
  <brief_title>Point of Care Testing for Presence of Current and or Previous T. Gondii Infection</brief_title>
  <official_title>Feasibility Study for Finger Prick Testing of Presence of Current and or Previous T. Gondii Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Chicago</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is part of a feasibility study to compare the predicate standard FDA cleared test for&#xD;
      serum to a point of care test Toxoplasma ICT IgG-IgM BK produced by LD Bio Diagnostic. The&#xD;
      specificity and sensitivity in testing serum and whole blood will be compared. This study&#xD;
      includes 70 persons either pregnant or non pregnant.&#xD;
&#xD;
      This is being done in accordance with FDA requirements for clearance of a testing device . We&#xD;
      will use a standard FDA cleared test in all studies. The FDA has suggested that we submit a&#xD;
      pre subQ for a 510K and dual CLIA waiver.&#xD;
&#xD;
      This allows us also to determine feasibility of use of the predicate test in conjunction with&#xD;
      the experimental test with volunteers, including men, women, and pregnant women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will determine the feasibility of using the point of care Toxoplasma ICT IgG-IgM&#xD;
      BK test produced by LD Bio Diagnostic to detect Toxoplasma gondii in clinical settings. The&#xD;
      result of testing from Toxoplasma ICT IgG-IgM BK test will be compared with the standard&#xD;
      predicate test. These results will be provided to FDA for consideration for clearance of this&#xD;
      test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 2020</start_date>
  <completion_date type="Anticipated">August 2021</completion_date>
  <primary_completion_date type="Anticipated">July 2021</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>subjects are recruited continuously and being tested with the study device as well as with the standard cleared test for the presence of Toxoplasma gondii antibody.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>congruence of Toxoplasma ICT IgG-IgM test and standard predicate test</measure>
    <time_frame>two weeks for initial result and a year for whole study</time_frame>
    <description>Toxoplasma ICT IgG-IgM test is feasible and the test result of the study device is same with the result of standard cleared test</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Toxoplasma Infections</condition>
  <arm_group>
    <arm_group_label>single group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>binary: positive or negative result</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>toxoplasma ICT IgG-IgM BK</intervention_name>
    <description>a point-of-care device, using blood from finger stick to measure the presence or absence of anti Toxoplasma gondii antibody</description>
    <arm_group_label>single group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  any adult who is willing to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Rima McLeod, M.D.</last_name>
    <phone>7738344130</phone>
    <email>rmcleod@uchicago.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ying Zhou, Ph.D.</last_name>
    <phone>7738344120</phone>
    <email>yzhou@bsd.uchicago.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Rima McLeod, M.D.</last_name>
      <phone>773-834-4130</phone>
      <email>rmcleod@uchicago.edu</email>
    </contact>
    <contact_backup>
      <last_name>Ying Zhou, Ph.D.</last_name>
      <phone>7738344120</phone>
      <email>yzhou@bsd.uchicago.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Lykins J, Li X, Levigne P, Zhou Y, El Bissati K, Clouser F, Wallon M, Morel F, Leahy K, El Mansouri B, Siddiqui M, Leong N, Michalowski M, Irwin E, Goodall P, Ismail M, Christmas M, Adlaoui EB, Rhajaoui M, Barkat A, Cong H, Begeman IJ, Lai BS, Contopoulos-Ioannidis DG, Montoya JG, Maldonado Y, Ramirez R, Press C, Peyron F, McLeod R. Rapid, inexpensive, fingerstick, whole-blood, sensitive, specific, point-of-care test for anti-Toxoplasma antibodies. PLoS Negl Trop Dis. 2018 Aug 16;12(8):e0006536. doi: 10.1371/journal.pntd.0006536. eCollection 2018 Aug. No abstract available.</citation>
    <PMID>30114251</PMID>
  </results_reference>
  <results_reference>
    <citation>Begeman IJ, Lykins J, Zhou Y, Lai BS, Levigne P, El Bissati K, Boyer K, Withers S, Clouser F, Noble AG, Rabiah P, Swisher CN, Heydemann PT, Contopoulos-Ioannidis DG, Montoya JG, Maldonado Y, Ramirez R, Press C, Stillwaggon E, Peyron F, McLeod R. Point-of-care testing for Toxoplasma gondii IgG/IgM using Toxoplasma ICT IgG-IgM test with sera from the United States and implications for developing countries. PLoS Negl Trop Dis. 2017 Jun 26;11(6):e0005670. doi: 10.1371/journal.pntd.0005670. eCollection 2017 Jun.</citation>
    <PMID>28650970</PMID>
  </results_reference>
  <results_reference>
    <citation>Gomez CA, Budvytyte LN, Press C, Zhou L, McLeod R, Maldonado Y, Montoya JG, Contopoulos-Ioannidis DG. Evaluation of Three Point-of-Care Tests for Detection of Toxoplasma Immunoglobulin IgG and IgM in the United States: Proof of Concept and Challenges. Open Forum Infect Dis. 2018 Oct 29;5(10):ofy215. doi: 10.1093/ofid/ofy215. eCollection 2018 Oct.</citation>
    <PMID>30393749</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>toxoplasma</keyword>
  <keyword>test</keyword>
  <keyword>feasibility</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04474132
org study id: IRB20-0442
nct id: NCT04474132
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
This is part of a feasibility study to compare the predicate standard FDA cleared test for
      serum to a point of care test Toxoplasma ICT IgG-IgM BK produced by LD Bio Diagnostic. The
      specificity and sensitivity in testing serum and whole blood will be compared. This study
      includes 70 persons either pregnant or non pregnant.

      This is being done in accordance with FDA requirements for clearance of a testing device . We
      will use a standard FDA cleared test in all studies. The FDA has suggested that we submit a
      pre subQ for a 510K and dual CLIA waiver.

      This allows us also to determine feasibility of use of the predicate test in conjunction with
      the experimental test with volunteers, including men, women, and pregnant women.
This study will determine the feasibility of using the point of care Toxoplasma ICT IgG-IgM
      BK test produced by LD Bio Diagnostic to detect Toxoplasma gondii in clinical settings. The
      result of testing from Toxoplasma ICT IgG-IgM BK test will be compared with the standard
      predicate test. These results will be provided to FDA for consideration for clearance of this
      test.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: subjects are recruited continuously and being tested with the study device as well as with the standard cleared test for the presence of Toxoplasma gondii antibody.
primary purpose: Diagnostic
masking: None (Open Label)
measure: congruence of Toxoplasma ICT IgG-IgM test and standard predicate test
time frame: two weeks for initial result and a year for whole study
description: Toxoplasma ICT IgG-IgM test is feasible and the test result of the study device is same with the result of standard cleared test
arm group label: single group
arm group type: Other
description: binary: positive or negative result
intervention type: Device
intervention name: toxoplasma ICT IgG-IgM BK
description: a point-of-care device, using blood from finger stick to measure the presence or absence of anti Toxoplasma gondii antibody
arm group label: single group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rima McLeod, M.D.
phone: 7738344130
email: rmcleod@uchicago.edu
last name: Ying Zhou, Ph.D.
phone: 7738344120
email: yzhou@bsd.uchicago.edu
facility: 
contact: 
contact backup: 
country: United States
citation: Lykins J, Li X, Levigne P, Zhou Y, El Bissati K, Clouser F, Wallon M, Morel F, Leahy K, El Mansouri B, Siddiqui M, Leong N, Michalowski M, Irwin E, Goodall P, Ismail M, Christmas M, Adlaoui EB, Rhajaoui M, Barkat A, Cong H, Begeman IJ, Lai BS, Contopoulos-Ioannidis DG, Montoya JG, Maldonado Y, Ramirez R, Press C, Peyron F, McLeod R. Rapid, inexpensive, fingerstick, whole-blood, sensitive, specific, point-of-care test for anti-Toxoplasma antibodies. PLoS Negl Trop Dis. 2018 Aug 16;12(8):e0006536. doi: 10.1371/journal.pntd.0006536. eCollection 2018 Aug. No abstract available.
PMID: 30114251
citation: Begeman IJ, Lykins J, Zhou Y, Lai BS, Levigne P, El Bissati K, Boyer K, Withers S, Clouser F, Noble AG, Rabiah P, Swisher CN, Heydemann PT, Contopoulos-Ioannidis DG, Montoya JG, Maldonado Y, Ramirez R, Press C, Stillwaggon E, Peyron F, McLeod R. Point-of-care testing for Toxoplasma gondii IgG/IgM using Toxoplasma ICT IgG-IgM test with sera from the United States and implications for developing countries. PLoS Negl Trop Dis. 2017 Jun 26;11(6):e0005670. doi: 10.1371/journal.pntd.0005670. eCollection 2017 Jun.
PMID: 28650970
citation: Gomez CA, Budvytyte LN, Press C, Zhou L, McLeod R, Maldonado Y, Montoya JG, Contopoulos-Ioannidis DG. Evaluation of Three Point-of-Care Tests for Detection of Toxoplasma Immunoglobulin IgG and IgM in the United States: Proof of Concept and Challenges. Open Forum Infect Dis. 2018 Oct 29;5(10):ofy215. doi: 10.1093/ofid/ofy215. eCollection 2018 Oct.
PMID: 30393749
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
sharing ipd: No