<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/NCT02194712</url>
  </required_header>
  <id_info>
    <org_study_id>CAA48780</org_study_id>
    <nct_id>NCT02194712</nct_id>
  </id_info>
  <brief_title>Detection of Schistosomiasis CAA in Travellers After High-risk Water Contact</brief_title>
  <official_title>Detection of Schistosomiasis Circulating Anodic Antigen (CAA) in Travellers After High-risk Water Contact</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meta Roestenberg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Leiden University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Schistosomiasis is increasingly encountered among travellers returning from the tropics and&#xD;
      is known for its focal endemicity, associated with the presence of the snail intermediate&#xD;
      host in fresh water. Because schistosomiasis in travellers is often atypical or asymptomatic&#xD;
      due to the low intensity of infection, many infections likely go undiagnosed and will develop&#xD;
      into chronic schistosomiasis. Conventional treatment of schistosomiasis in travellers with&#xD;
      praziquantel 40mg/kg daily dose is known for its modest success rate. Diagnosis of&#xD;
      schistosomiasis relies on egg detection, which has a poor sensitivity in low burden&#xD;
      infections, or serology, which is inadequate to monitor cure. The department of parasitology&#xD;
      of the Leiden University Medical Center has developed a novel diagnostic test based on the&#xD;
      up-converting phosphor technology (UCP) to detect circulating anodic antigen (CAA). This test&#xD;
      can be performed on serum and urine to detect low intensity schistosomiasis infections and&#xD;
      confirm cure after praziquantel treatment. This study will assess the performance of UCP-CAA&#xD;
      in travellers with high-risk water contact.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Actual">September 2019</completion_date>
  <primary_completion_date type="Actual">September 2019</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>The sensitivity and specificity of UCP-CAA</measure>
    <time_frame>12 weeks after last water contact</time_frame>
    <description>The diagnostic performance of UCP-CAA will be assessed by calculating the sensitivity and specificity of UCP-CAA measurement in travellers 12 weeks after reported high-risk water contact. Routine diagnostics performed by the individual centers, such as serology, will be the standard against which sensitivity (number of cases positive in both tests / number of cases positive in routine diagnostics) and specificity (number of cases negative in both tests / number of cases negative in routine diagnostics) is calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The percentage of travellers with persisting positive UCP-CAA six weeks after conventional praziquantel treatment</measure>
    <time_frame>six weeks after praziquantel treatment</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">106</enrollment>
  <condition>Schistosomiasis</condition>
  <arm_group>
    <arm_group_label>travellers</arm_group_label>
    <description>travellers with recent (&lt;12 weeks) high risk water contact are included in the study and asked to provide samples for CAA testing</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Urine CAA detection</intervention_name>
    <description>In addition to routine diagnostics, serum and urine samples are stored for retrospective UCP-CAA antigen determination.</description>
    <arm_group_label>travellers</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      serum, urine and faeces&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Travellers with reported high-risk water contact &lt;12 weeks before inclusion.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Any self-reported high risk water contact, including wading, showering, surfing,&#xD;
             walking along wet shore bare-footed or washing with water from a high-risk source,&#xD;
             within 12 weeks prior to reporting to the outpatient department&#xD;
&#xD;
          2. Agreement to perform routine diagnostic procedures to diagnose schistosomiasis&#xD;
             infection&#xD;
&#xD;
          3. Willing to provide a maximum of three additional blood samples in addition to routine&#xD;
             diagnostic procedures&#xD;
&#xD;
          4. Able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous treatment for schistosomiasis&#xD;
&#xD;
          2. Known positive schistosomiasis serology&#xD;
&#xD;
          3. The use of immunosuppressive or immunomodulatory drugs at presentation that compromise&#xD;
             the interpretation of schistosomiasis serology&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>M.P. Grobusch, Prof. MD. PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Amsterdam UMC, location VUmc</affiliation>
  </overall_official>
  <overall_official>
    <last_name>P.J.J. van Genderen, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Harbour Hospital Rotterdam</affiliation>
  </overall_official>
  <overall_official>
    <last_name>M. Roestenberg, MD. PhD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Leiden University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Academic Medical Center</name>
      <address>
        <city>Amsterdam</city>
        <zip>1100 DD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leiden University Medical Center</name>
      <address>
        <city>Leiden</city>
        <zip>2333 ZA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harbour Hospital</name>
      <address>
        <city>Rotterdam</city>
        <zip>3011 TG</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <results_reference>
    <citation>Casacuberta-Partal M, Janse JJ, van Schuijlenburg R, de Vries JJC, Erkens MAA, Suijk K, van Aalst M, Maas JJ, Grobusch MP, van Genderen PJJ, de Dood C, Corstjens PLAM, van Dam GJ, van Lieshout L, Roestenberg M. Antigen-based diagnosis of Schistosoma infection in travellers: a prospective study. J Travel Med. 2020 Jul 14;27(4):taaa055. doi: 10.1093/jtm/taaa055.</citation>
    <PMID>32307517</PMID>
  </results_reference>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>November 16, 2020</last_update_submitted>
  <last_update_submitted_qc>November 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Leiden University Medical Center</investigator_affiliation>
    <investigator_full_name>Meta Roestenberg</investigator_full_name>
    <investigator_title>M.Roestenberg, MD PhD</investigator_title>
  </responsible_party>
  <keyword>circulating anodic antigen</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schistosomiasis</mesh_term>
  </condition_browse>
  <!-- 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/NCT02194712
org study id: CAA48780
nct id: NCT02194712
lead sponsor: 
has dmc: No
Schistosomiasis is increasingly encountered among travellers returning from the tropics and
      is known for its focal endemicity, associated with the presence of the snail intermediate
      host in fresh water. Because schistosomiasis in travellers is often atypical or asymptomatic
      due to the low intensity of infection, many infections likely go undiagnosed and will develop
      into chronic schistosomiasis. Conventional treatment of schistosomiasis in travellers with
      praziquantel 40mg/kg daily dose is known for its modest success rate. Diagnosis of
      schistosomiasis relies on egg detection, which has a poor sensitivity in low burden
      infections, or serology, which is inadequate to monitor cure. The department of parasitology
      of the Leiden University Medical Center has developed a novel diagnostic test based on the
      up-converting phosphor technology (UCP) to detect circulating anodic antigen (CAA). This test
      can be performed on serum and urine to detect low intensity schistosomiasis infections and
      confirm cure after praziquantel treatment. This study will assess the performance of UCP-CAA
      in travellers with high-risk water contact.
observational model: Cohort
time perspective: Prospective
measure: The sensitivity and specificity of UCP-CAA
time frame: 12 weeks after last water contact
description: The diagnostic performance of UCP-CAA will be assessed by calculating the sensitivity and specificity of UCP-CAA measurement in travellers 12 weeks after reported high-risk water contact. Routine diagnostics performed by the individual centers, such as serology, will be the standard against which sensitivity (number of cases positive in both tests / number of cases positive in routine diagnostics) and specificity (number of cases negative in both tests / number of cases negative in routine diagnostics) is calculated.
measure: The percentage of travellers with persisting positive UCP-CAA six weeks after conventional praziquantel treatment
time frame: six weeks after praziquantel treatment
arm group label: travellers
description: travellers with recent (<12 weeks) high risk water contact are included in the study and asked to provide samples for CAA testing
intervention type: Other
intervention name: Urine CAA detection
description: In addition to routine diagnostics, serum and urine samples are stored for retrospective UCP-CAA antigen determination.
arm group label: travellers
serum, urine and faeces
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: M.P. Grobusch, Prof. MD. PhD
role: Principal Investigator
affiliation: Amsterdam UMC, location VUmc
last name: P.J.J. van Genderen, MD, PhD
role: Principal Investigator
affiliation: Harbour Hospital Rotterdam
last name: M. Roestenberg, MD. PhD.
role: Principal Investigator
affiliation: Leiden University Medical Center
facility: 
facility: 
facility: 
country: Netherlands
citation: Casacuberta-Partal M, Janse JJ, van Schuijlenburg R, de Vries JJC, Erkens MAA, Suijk K, van Aalst M, Maas JJ, Grobusch MP, van Genderen PJJ, de Dood C, Corstjens PLAM, van Dam GJ, van Lieshout L, Roestenberg M. Antigen-based diagnosis of Schistosoma infection in travellers: a prospective study. J Travel Med. 2020 Jul 14;27(4):taaa055. doi: 10.1093/jtm/taaa055.
PMID: 32307517
responsible party type: Sponsor-Investigator
investigator affiliation: Leiden University Medical Center
investigator full name: Meta Roestenberg
investigator title: M.Roestenberg, MD PhD
mesh term: Schistosomiasis