<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/NCT03837431</url>
  </required_header>
  <id_info>
    <org_study_id>1219/18</org_study_id>
    <nct_id>NCT03837431</nct_id>
  </id_info>
  <brief_title>Cutaneous Leishmaniasis Diagnostic Study</brief_title>
  <official_title>Diagnosis of Cutaneous Leishmaniasis Using the CL-Detect Rapid Test in Ethiopia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute of Tropical Medicine, Belgium</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institute of Tropical Medicine, Belgium</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>
      The performance of the CL Detect Rapid test will be tested in individuals with suspected&#xD;
      cutaneous leishmaniasis in Ethiopia using both skin slit and dental broach samples against a&#xD;
      combined reference of microscopy and PCR. Alternative sampling methods will also be&#xD;
      evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cutaneous Leishmaniasis is common in Ethiopia and mainly affects the poor living in rural&#xD;
      areas. Diagnosis of CL routinely uses invasive skin slits which are examined with microscopy,&#xD;
      requiring trained staff and an equipped lab. A new rapid diagnostic test for CL which may be&#xD;
      used in the field has been developed and validated in several countries where other&#xD;
      Leishmania species are present. Less invasive tape sampling has also become available.&#xD;
      Whether this new RDT and alternative sampling methods can be used in Ethiopia is unclear.&#xD;
&#xD;
      The performance of the CL detect Rapid Test against a combined reference (microscopy and PCR)&#xD;
      and alternative sample collection methods will be tested in CL suspected individuals in&#xD;
      North-West Ethiopia in a cross-sectional study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 13, 2019</start_date>
  <completion_date type="Actual">January 31, 2023</completion_date>
  <primary_completion_date type="Actual">August 12, 2022</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sensitivity, specificity of CL detect Rapid Test using skin slit sampling</measure>
    <time_frame>February 2019</time_frame>
    <description>% test positive/negative compared against a combined reference of microscopy and PCR with skin slit sampling(positive if any of the two are positive)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sensitivity, specificity of CL detect Rapid Test using dental broach sampling</measure>
    <time_frame>February 2019</time_frame>
    <description>CL detect Rapid Test against combined reference of microscopy and PCR using skin slit sampling</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity, specificity of CL detect Rapid Test with skin slit or dental broach sampling</measure>
    <time_frame>May 2018</time_frame>
    <description>CL detect Rapid Test with skin slit sample against CL detect Rapid Test with dental broach sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity, specificity of CL detect Rapid Test compared to routine</measure>
    <time_frame>February 2019</time_frame>
    <description>CL detect Rapid Test positive/negative with skin slit sample compared to microscopy with skin slit sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity, specificity of dental broach sample compared to skin slit sample</measure>
    <time_frame>February 2019</time_frame>
    <description>PCR with dental broach compared to PCR with skin slit sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity, specificity of tape disc sampling</measure>
    <time_frame>February 2019</time_frame>
    <description>PCR with tape disc sampling compared to PCR with skin slit sampling</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity, specificity of routine testing</measure>
    <time_frame>February 2019</time_frame>
    <description>Microscopy with skin slit sampling compared to PCR with skin slit sampling</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Species identification</measure>
    <time_frame>February 2019</time_frame>
    <description>For selected CL lesions species identification will be done</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunomodulatory mediators in CL lesions using non-invasive sampling</measure>
    <time_frame>February 2019</time_frame>
    <description>Tape disc samples will be used and correlation with lesion severity will be assessed</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">351</enrollment>
  <condition>Cutaneous Leishmaniases</condition>
  <arm_group>
    <arm_group_label>CL suspicion</arm_group_label>
    <description>Individuals presenting with clinical suspicion of CL</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Skin slit</intervention_name>
    <description>Skin slit microscopy, RDT and PCR</description>
    <arm_group_label>CL suspicion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Dental broach</intervention_name>
    <description>Dental broach RDT and PCR</description>
    <arm_group_label>CL suspicion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Tape disc</intervention_name>
    <description>Tape disc PCR</description>
    <arm_group_label>CL suspicion</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Skin samples will be stored (skin slit smear, dental broach sample, tape sample) for a period&#xD;
      of one year after the end of the study for quality assurance testing. If patients consented&#xD;
      to long-term storage and secondary use of their samples, the skin samples will be stored for&#xD;
      a period up to 25 years.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients presenting at the LRTC with clinically suspected CL during the study period will&#xD;
        be screened for eligibility. Suspicion for CL is assessed by physicians as per routine&#xD;
        care. In general, children are included in the study population since they are commonly&#xD;
        affected, and also make up the majority of DCL patients. Very young children below the age&#xD;
        of two are excluded as was done in other studies18 since the study does require more&#xD;
        potentially painful procedures as compared to the routine diagnostic procedures.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Clinical suspicion of CL&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ≤ 2 years of age&#xD;
&#xD;
          -  Not willing or able to provide consent/assent&#xD;
&#xD;
          -  CL presentation with only lesions for which skin slit samples cannot be obtained (e.g.&#xD;
             eyelids)&#xD;
&#xD;
          -  Co-morbidity with visceral leishmaniasis&#xD;
&#xD;
          -  On CL treatment at time of enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Johan van Griensven, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Institute of Tropical Medicine, Antwerp, Belgium</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rezika Mohammed, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Leishmania Research and Treatment Center, University of Gondar hospital</name>
      <address>
        <city>Gondar</city>
        <country>Ethiopia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ethiopia</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>February 8, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>February 28, 2023</last_update_submitted>
  <last_update_submitted_qc>February 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cutaneous</keyword>
  <keyword>Leishmaniasis</keyword>
  <keyword>Ethiopia</keyword>
  <keyword>RDT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leishmaniasis</mesh_term>
    <mesh_term>Leishmaniasis, Cutaneous</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD accessible by managed access</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>After completion of the primary publication</ipd_time_frame>
    <ipd_access_criteria>Applicants will need to fill out a data access request form</ipd_access_criteria>
    <ipd_url>https://www.itg.be/E/data-sharing-open-access</ipd_url>
  </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/NCT03837431
org study id: 1219/18
nct id: NCT03837431
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The performance of the CL Detect Rapid test will be tested in individuals with suspected
      cutaneous leishmaniasis in Ethiopia using both skin slit and dental broach samples against a
      combined reference of microscopy and PCR. Alternative sampling methods will also be
      evaluated.
Cutaneous Leishmaniasis is common in Ethiopia and mainly affects the poor living in rural
      areas. Diagnosis of CL routinely uses invasive skin slits which are examined with microscopy,
      requiring trained staff and an equipped lab. A new rapid diagnostic test for CL which may be
      used in the field has been developed and validated in several countries where other
      Leishmania species are present. Less invasive tape sampling has also become available.
      Whether this new RDT and alternative sampling methods can be used in Ethiopia is unclear.

      The performance of the CL detect Rapid Test against a combined reference (microscopy and PCR)
      and alternative sample collection methods will be tested in CL suspected individuals in
      North-West Ethiopia in a cross-sectional study.
observational model: Cohort
time perspective: Cross-Sectional
measure: Sensitivity, specificity of CL detect Rapid Test using skin slit sampling
time frame: February 2019
description: % test positive/negative compared against a combined reference of microscopy and PCR with skin slit sampling(positive if any of the two are positive)
measure: Sensitivity, specificity of CL detect Rapid Test using dental broach sampling
time frame: February 2019
description: CL detect Rapid Test against combined reference of microscopy and PCR using skin slit sampling
measure: Sensitivity, specificity of CL detect Rapid Test with skin slit or dental broach sampling
time frame: May 2018
description: CL detect Rapid Test with skin slit sample against CL detect Rapid Test with dental broach sample
measure: Sensitivity, specificity of CL detect Rapid Test compared to routine
time frame: February 2019
description: CL detect Rapid Test positive/negative with skin slit sample compared to microscopy with skin slit sample
measure: Sensitivity, specificity of dental broach sample compared to skin slit sample
time frame: February 2019
description: PCR with dental broach compared to PCR with skin slit sample
measure: Sensitivity, specificity of tape disc sampling
time frame: February 2019
description: PCR with tape disc sampling compared to PCR with skin slit sampling
measure: Sensitivity, specificity of routine testing
time frame: February 2019
description: Microscopy with skin slit sampling compared to PCR with skin slit sampling
measure: Species identification
time frame: February 2019
description: For selected CL lesions species identification will be done
measure: Immunomodulatory mediators in CL lesions using non-invasive sampling
time frame: February 2019
description: Tape disc samples will be used and correlation with lesion severity will be assessed
arm group label: CL suspicion
description: Individuals presenting with clinical suspicion of CL
intervention type: Diagnostic Test
intervention name: Skin slit
description: Skin slit microscopy, RDT and PCR
arm group label: CL suspicion
intervention type: Diagnostic Test
intervention name: Dental broach
description: Dental broach RDT and PCR
arm group label: CL suspicion
intervention type: Diagnostic Test
intervention name: Tape disc
description: Tape disc PCR
arm group label: CL suspicion
Skin samples will be stored (skin slit smear, dental broach sample, tape sample) for a period
      of one year after the end of the study for quality assurance testing. If patients consented
      to long-term storage and secondary use of their samples, the skin samples will be stored for
      a period up to 25 years.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: N/A
healthy volunteers: No
last name: Johan van Griensven, MD, PhD
role: Study Chair
affiliation: Institute of Tropical Medicine, Antwerp, Belgium
last name: Rezika Mohammed, MD
role: Principal Investigator
affiliation: College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia
facility: 
country: Ethiopia
responsible party type: Sponsor
mesh term: Leishmaniasis
mesh term: Leishmaniasis, Cutaneous
sharing ipd: Yes
ipd description: IPD accessible by managed access
ipd info type: Study Protocol
ipd time frame: After completion of the primary publication
ipd access criteria: Applicants will need to fill out a data access request form
ipd url: https://www.itg.be/E/data-sharing-open-access