<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/NCT03762070</url>
  </required_header>
  <id_info>
    <org_study_id>LRDD-PERU-02</org_study_id>
    <nct_id>NCT03762070</nct_id>
  </id_info>
  <brief_title>Evaluation of a Diagnostic Device, CL Detect™ Rapid Test, for the Diagnosis of Cutaneous Leishmaniasis in Peru</brief_title>
  <official_title>Evaluation of a Diagnostic Device, CL Detect™ Rapid Test, for the Diagnosis of Cutaneous Leishmaniasis in Peru</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Naval Medical Research Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Naval Medical Research Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Determine the sensitivity and specificity of the FDA-cleared CL Detect™ Rapid Test in Peru,&#xD;
      using a test procedure that was modified from that described in the device instructions to&#xD;
      optimize these parameters for the detection of Leishmania species identified in Peru.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Observational study of a FDA cleared device, the CL Detect™ Rapid Test. Data for the 510(K)&#xD;
      was supported by a sensitivity study conducted in Tunisia, Old world Leishamania major and a&#xD;
      specificity study conducted in the United Sates. Sensitivity and specificity data collected&#xD;
      recently in Peru (2014-2015), by the Instituto de Medicina Tropical Alexander von Humbolt,&#xD;
      supports the idea that the sensitivity of the CL Detect™ Rapid Test can be drastically&#xD;
      increased for New World Leishmania species. The study is a single trial, with two clinical&#xD;
      sites, NAMRU-6, Puerto Maldonado and the Alexander von Humboldt Tropical Medicine Institute&#xD;
      in Lima. The objective of the study is to determine the sensitivity and specificity of the&#xD;
      FDA-cleared CL Detect™ Rapid Test, using an optimized test procedure determined from a pilot&#xD;
      study conducted in Peru. Two modifications to the test procedure (marketed device&#xD;
      instructions) are included in this study: 1) increase in extraction time in lysis buffer from&#xD;
      5 to 10 minutes to 20 to 30 minutes and 2) a 20 μl increase in the volume of the sample to&#xD;
      add to the test strip, from 20 μl to 40 μl. The gold standard for Leishmania diagnosis, which&#xD;
      is microscopic identification of amastigotes in stained lesion sample, will be used as a&#xD;
      control.&#xD;
&#xD;
      Participants will be patients who present for medical consultation due to a suspected CL&#xD;
      lesion. After obtaining informed consent and screening the participant for eligibility, we&#xD;
      will collect and test at most 4 samples from the index lesion in the following order:&#xD;
&#xD;
        1. one sample obtained with a dental broach for use with the CL Detect™ Rapid Test;&#xD;
&#xD;
        2. one sample obtained by scraping for microscopic identification of amastigotes; and&#xD;
&#xD;
        3. one sample obtained by scraping for Leishmania speciation by PCR; and&#xD;
&#xD;
        4. when possible, (depending on the size of the lesion), one sample from a different site&#xD;
           of the same lesion, obtained by scraping for use with the CL Detect™ Rapid Test. PCR&#xD;
           analysis will be performed by NAMRU-6 for possible exploratory analyses including&#xD;
           species identification. If the etiologies of the lesions that are negative for&#xD;
           Leishmania are known, they will be reported. Participants with a positive diagnosis of&#xD;
           leishmaniasis by microscopy or other methods will be referred for standard of care&#xD;
           treatment in Peru by the attending physician of the Peruvian Ministry of Health.&#xD;
           Treatment is not part of this study. If a participant's lesions are negative for&#xD;
           Leishmania, standard of care follow-up testing will be performed, either at the study&#xD;
           site, or (when indicated) in another hospital.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 2, 2018</start_date>
  <completion_date type="Anticipated">April 2019</completion_date>
  <primary_completion_date type="Anticipated">March 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The performance (sensitivity and specificity) of the CL Detect™ Rapid Test</measure>
    <time_frame>1 day</time_frame>
    <description>Sensitivity and specificity of CL Detect™ Rapid Test will be determined by comparing with the gold standard, microscopy of stained lesion samples for identification of Leishmania amastigotes. The following definitions apply to the calculation of assay sensitivity and specificity: 1. True positive: Positive by both the CL Detect™ Rapid Test and the reference method. 2. False positive: Positive by the CL Detect™ Rapid Test but negative for the reference method. 3. True negative: Negative by both the CL Detect™ Rapid Test and the reference method. 4. False negative: Negative by the CL Detect™ Rapid Test but positive for the reference method.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Determine the sensitivity and specificity of the FDA-cleared CL Detect™ Rapid Test when scraping is used to obtain tissue samples.</measure>
    <time_frame>1 day</time_frame>
    <description>Determine the sensitivity and specificity of the FDA-cleared CL Detect™ Rapid Test when scraping is used to obtain tissue samples.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Leishmaniasis, Cutaneous</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CL Detect™ Rapid Test</intervention_name>
    <description>Observational study of a FDA cleared device, the CL Detect™ Rapid Test.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population consists of male and female participants, ages 18 years and older,&#xD;
        with a clinically suspected CL lesion. It is estimated that up to 200 participants may need&#xD;
        to be consented, screened, and tested in order to obtain 100 participants/samples who are&#xD;
        positive by microscopy for Leishmania, using minimally modified (from the device&#xD;
        instructional insert) test conditions determined to be optimal in a pilot study. If a&#xD;
        higher percentage of participants are negative by microscopy than is estimated, then the&#xD;
        total sample size will be increased to obtain a total of 100 participants positive by&#xD;
        microscopy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 18 years of age and generally healthy.&#xD;
&#xD;
          -  Able to provide written informed consent.&#xD;
&#xD;
          -  Index lesion present that is suspicious for CL, as defined by the following criteria&#xD;
             for an index lesion:&#xD;
&#xD;
               1. less than 2 months in age&#xD;
&#xD;
               2. primarily ulcerative, i.e. not purely verrucous or nodular&#xD;
&#xD;
               3. no clear clinical evidence of cellulitis&#xD;
&#xD;
               4. location suitable for collecting samples by dental broach and scraping.&#xD;
&#xD;
          -  Capable of understanding and complying with the protocol, in the opinion of the&#xD;
             evaluator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Received treatment for leishmaniasis within the last 2 months prior to evaluation.&#xD;
&#xD;
          -  In the opinion of the investigator, evidence of manipulation of the lesion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Max Grogl, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Scientific Director</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Max Grogl, Ph.D.</last_name>
    <phone>51-1-614-4159</phone>
    <email>max.grogl1.civ@mail.mil</email>
  </overall_contact>
  <location>
    <facility>
      <name>Universidad Peruana Cayetano Heredia (UPCH)</name>
      <address>
        <city>Lima</city>
        <country>Peru</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ana Ramos, M.D.</last_name>
      <email>ana.ramos.t@upch.pe</email>
    </contact>
    <investigator>
      <last_name>Alejandro Llanos-Cuentas, M.D., Ph.D</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>U.S. Naval Medical Research Center Unit No. 6 (NAMRU-6)</name>
      <address>
        <city>Puerto Maldonado</city>
        <country>Peru</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Luis Angel Rosales</last_name>
      <phone>51-982-328-888</phone>
    </contact>
  </location>
  <location_countries>
    <country>Peru</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>November 30, 2018</last_update_submitted>
  <last_update_submitted_qc>November 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Naval Medical Research Center</investigator_affiliation>
    <investigator_full_name>Dr. Max Grogl</investigator_full_name>
    <investigator_title>Scientific Director</investigator_title>
  </responsible_party>
  <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>
  <!-- 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/NCT03762070
org study id: LRDD-PERU-02
nct id: NCT03762070
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Determine the sensitivity and specificity of the FDA-cleared CL Detect™ Rapid Test in Peru,
      using a test procedure that was modified from that described in the device instructions to
      optimize these parameters for the detection of Leishmania species identified in Peru.
Observational study of a FDA cleared device, the CL Detect™ Rapid Test. Data for the 510(K)
      was supported by a sensitivity study conducted in Tunisia, Old world Leishamania major and a
      specificity study conducted in the United Sates. Sensitivity and specificity data collected
      recently in Peru (2014-2015), by the Instituto de Medicina Tropical Alexander von Humbolt,
      supports the idea that the sensitivity of the CL Detect™ Rapid Test can be drastically
      increased for New World Leishmania species. The study is a single trial, with two clinical
      sites, NAMRU-6, Puerto Maldonado and the Alexander von Humboldt Tropical Medicine Institute
      in Lima. The objective of the study is to determine the sensitivity and specificity of the
      FDA-cleared CL Detect™ Rapid Test, using an optimized test procedure determined from a pilot
      study conducted in Peru. Two modifications to the test procedure (marketed device
      instructions) are included in this study: 1) increase in extraction time in lysis buffer from
      5 to 10 minutes to 20 to 30 minutes and 2) a 20 μl increase in the volume of the sample to
      add to the test strip, from 20 μl to 40 μl. The gold standard for Leishmania diagnosis, which
      is microscopic identification of amastigotes in stained lesion sample, will be used as a
      control.

      Participants will be patients who present for medical consultation due to a suspected CL
      lesion. After obtaining informed consent and screening the participant for eligibility, we
      will collect and test at most 4 samples from the index lesion in the following order:

        1. one sample obtained with a dental broach for use with the CL Detect™ Rapid Test;

        2. one sample obtained by scraping for microscopic identification of amastigotes; and

        3. one sample obtained by scraping for Leishmania speciation by PCR; and

        4. when possible, (depending on the size of the lesion), one sample from a different site
           of the same lesion, obtained by scraping for use with the CL Detect™ Rapid Test. PCR
           analysis will be performed by NAMRU-6 for possible exploratory analyses including
           species identification. If the etiologies of the lesions that are negative for
           Leishmania are known, they will be reported. Participants with a positive diagnosis of
           leishmaniasis by microscopy or other methods will be referred for standard of care
           treatment in Peru by the attending physician of the Peruvian Ministry of Health.
           Treatment is not part of this study. If a participant's lesions are negative for
           Leishmania, standard of care follow-up testing will be performed, either at the study
           site, or (when indicated) in another hospital.
observational model: Case-Only
time perspective: Cross-Sectional
measure: The performance (sensitivity and specificity) of the CL Detect™ Rapid Test
time frame: 1 day
description: Sensitivity and specificity of CL Detect™ Rapid Test will be determined by comparing with the gold standard, microscopy of stained lesion samples for identification of Leishmania amastigotes. The following definitions apply to the calculation of assay sensitivity and specificity: 1. True positive: Positive by both the CL Detect™ Rapid Test and the reference method. 2. False positive: Positive by the CL Detect™ Rapid Test but negative for the reference method. 3. True negative: Negative by both the CL Detect™ Rapid Test and the reference method. 4. False negative: Negative by the CL Detect™ Rapid Test but positive for the reference method.
measure: Determine the sensitivity and specificity of the FDA-cleared CL Detect™ Rapid Test when scraping is used to obtain tissue samples.
time frame: 1 day
description: Determine the sensitivity and specificity of the FDA-cleared CL Detect™ Rapid Test when scraping is used to obtain tissue samples.
intervention type: Device
intervention name: CL Detect™ Rapid Test
description: Observational study of a FDA cleared device, the CL Detect™ Rapid Test.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Max Grogl, Ph.D.
role: Principal Investigator
affiliation: Scientific Director
last name: Max Grogl, Ph.D.
phone: 51-1-614-4159
email: max.grogl1.civ@mail.mil
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
country: Peru
responsible party type: Principal Investigator
investigator affiliation: Naval Medical Research Center
investigator full name: Dr. Max Grogl
investigator title: Scientific Director
mesh term: Leishmaniasis
mesh term: Leishmaniasis, Cutaneous