<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/NCT02254564</url>
  </required_header>
  <id_info>
    <org_study_id>Scabies 1</org_study_id>
    <nct_id>NCT02254564</nct_id>
  </id_info>
  <brief_title>PCR (Polymerase Chain Reaction) Assay for Diagnosis of Sarcoptes Scabiei</brief_title>
  <official_title>PCR (Polymerase Chain Reaction) Assay for Diagnosis of Sarcoptes Scabiei</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seton Healthcare Family</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seton Healthcare Family</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective of this study is to identify unique DNA sequences within the genome of&#xD;
      human scabies that can be utilized to identify the parasite through PCR.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main objective of this proposed study is to identify unique DNA sequences within the&#xD;
      genome of human scabies that can be utilized to identify the parasite through polymerase&#xD;
      chain reaction or PCR. The goal of the project is to design an assay that can distinguish&#xD;
      samples from skin scrapings containing scabies mites, eggs, or fecal material confirmed by&#xD;
      clinic based microscopic evaluation (gold standard) from negative controls (i.e. scrapings&#xD;
      for tinea and/or demodex folliculitis) that do not contain Sarcoptes scabiei. We hypothesize&#xD;
      that specifically amplifying the unique regions of the Scabies genome using PCR can serve as&#xD;
      a means to diagnosis infestations in humans. To address this question, we will optimize PCR&#xD;
      amplification of known scabies samples then apply our procedure to DNA extracted from patient&#xD;
      samples.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Actual">October 31, 2017</completion_date>
  <primary_completion_date type="Actual">August 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Identification of DNA sequences within scabies that can be used to identify the parasite through PCR</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">17</enrollment>
  <condition>Scabies</condition>
  <arm_group>
    <arm_group_label>Positive Scrapings</arm_group_label>
    <description>Skin scrapings that are positive for scabies</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Negative Controls</arm_group_label>
    <description>collect negative controls from patients in whom tinea (superficial fungal infection) was clinically suspected. Samples from patients with demodex folliculitis (a mite that is commonly found in oil glands on the face) are also intended to be used as negative controls as well.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Superficial skin scrapings scales that are collected on microscope slides, which are used to&#xD;
      determine diagnosis in clinical settings. After clinicians view the slide under the&#xD;
      microscope, the slide is then discarded.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients will be recruited upon identifying of scabies by microscopy or when a scraping is&#xD;
        performed for suspected tinea or demodex folliculitis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Male/Female of all ages whose standard clinical treatment produces one or more of&#xD;
             the following:&#xD;
&#xD;
               -  Slides from skin scrapings containing scabies mites, eggs, and/or fecal material&#xD;
&#xD;
               -  Slides from skin scrapings of suspected tinea&#xD;
&#xD;
               -  Slides from skin scrapings of demodex mites&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Patients who are clinically concerning for having both scabies and tinea/demodex&#xD;
             folliculitis to avoid contamination of positive and negative controls in the same&#xD;
             sample. Subjects or guardians who cannot understand and read English and so are unable&#xD;
             to consent to participation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dayna Diven, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seton Healthcare Family</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seton Family of Hospitals- Trinity and Hays Clinic</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Center Brackenridge and Paul Bass Clinic</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Physicians at Trinity</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seton Family of Hospitals- Dell Children's Medical Center of Central Texas and Specially for Children</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78723</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seton Family of Hospitals- Seton Luling Family Medicine Clinic and Lockhart Specialty Clinic</name>
      <address>
        <city>Lockhart</city>
        <state>Texas</state>
        <zip>78644</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>June 29, 2018</last_update_submitted>
  <last_update_submitted_qc>June 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seton Healthcare Family</investigator_affiliation>
    <investigator_full_name>Dayna Diven</investigator_full_name>
    <investigator_title>Physician</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Scabies</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/NCT02254564
org study id: Scabies 1
nct id: NCT02254564
lead sponsor: 
has dmc: No
The main objective of this study is to identify unique DNA sequences within the genome of
      human scabies that can be utilized to identify the parasite through PCR.
The main objective of this proposed study is to identify unique DNA sequences within the
      genome of human scabies that can be utilized to identify the parasite through polymerase
      chain reaction or PCR. The goal of the project is to design an assay that can distinguish
      samples from skin scrapings containing scabies mites, eggs, or fecal material confirmed by
      clinic based microscopic evaluation (gold standard) from negative controls (i.e. scrapings
      for tinea and/or demodex folliculitis) that do not contain Sarcoptes scabiei. We hypothesize
      that specifically amplifying the unique regions of the Scabies genome using PCR can serve as
      a means to diagnosis infestations in humans. To address this question, we will optimize PCR
      amplification of known scabies samples then apply our procedure to DNA extracted from patient
      samples.
observational model: Case-Control
time perspective: Prospective
measure: Identification of DNA sequences within scabies that can be used to identify the parasite through PCR
time frame: 1 year
arm group label: Positive Scrapings
description: Skin scrapings that are positive for scabies
arm group label: Negative Controls
description: collect negative controls from patients in whom tinea (superficial fungal infection) was clinically suspected. Samples from patients with demodex folliculitis (a mite that is commonly found in oil glands on the face) are also intended to be used as negative controls as well.
Superficial skin scrapings scales that are collected on microscope slides, which are used to
      determine diagnosis in clinical settings. After clinicians view the slide under the
      microscope, the slide is then discarded.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Dayna Diven, MD
role: Principal Investigator
affiliation: Seton Healthcare Family
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Seton Healthcare Family
investigator full name: Dayna Diven
investigator title: Physician
mesh term: Scabies
sharing ipd: No