<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/NCT03767114</url>
  </required_header>
  <id_info>
    <org_study_id>EgyERAP</org_study_id>
    <nct_id>NCT03767114</nct_id>
  </id_info>
  <brief_title>Estimation of Level of ERAP1 Expression in Lesional and Non Lesional Skin of Psoraitic Patients and Healthy Controls.</brief_title>
  <official_title>Estimation of Level of ERAP1 Expression in Lesional and Non Lesional Skin of Psoraitic Patients and Healthy Controls.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kasr El Aini Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kasr El Aini Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A 4mm Punch biopsy is obtained from lesional and non lesional skin of 25 psoraitic patients&#xD;
      as well as of 30 controls.&#xD;
&#xD;
      Skin biopsy from patients (psoriasis lesional and non lesional) &amp; control will be kept in&#xD;
      lysis solution (which contains RNAase inhibitor) for the stability of the parameter to be&#xD;
      assessed. ERAP-1 gene expression will Research Template 5 Final Version: 8/3/2 016 be&#xD;
      detected by quantitative real time -PCR, which include RNA extraction, cDNA synthesis &amp; PCR.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">June 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Estimation of lesional ERAP1 in psoriatic skin</measure>
    <time_frame>Maximum 2 years</time_frame>
    <description>DPCRetection of level of expression of ERAP 1 in lesional skin of psoriasis patients by RT-</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Estimation of non lesional ERAP1 in psoriatic skin</measure>
    <time_frame>Maximum 2 years</time_frame>
    <description>Detection of level of expression of ERAP 1 in non lesional skin of psoriasis patients by RT-PCR.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Psoriasis</condition>
  <arm_group>
    <arm_group_label>cases of psoriasis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>group of 25 cases of psoriasis subjected to skin biopsy for detection of lesional and non lesional expression of ERAP1 by RT-PCR</description>
  </arm_group>
  <arm_group>
    <arm_group_label>normal controls</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>group of 30 age and sex matched healthy controls o subjected to skin biopsy from normal skin for detection of expression of ERAP1 by RT-PCR</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>RT-PCR for ERAP1 detection</intervention_name>
    <description>Reverse transcriptase -Polymerase Chain Reaction for ERAP1 detection</description>
    <arm_group_label>cases of psoriasis</arm_group_label>
    <arm_group_label>normal controls</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with psoriasis vulgaris&#xD;
&#xD;
          -  patients over 18 years of age&#xD;
&#xD;
          -  both sexes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients on treatment for psoriasis within the last two months&#xD;
&#xD;
          -  assoiciated autoimmune diseases eg SLE&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>December 5, 2018</last_update_submitted>
  <last_update_submitted_qc>December 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kasr El Aini Hospital</investigator_affiliation>
    <investigator_full_name>Rana F Hilal, MD</investigator_full_name>
    <investigator_title>Lecturer of dermatology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</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/NCT03767114
org study id: EgyERAP
nct id: NCT03767114
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A 4mm Punch biopsy is obtained from lesional and non lesional skin of 25 psoraitic patients
      as well as of 30 controls.

      Skin biopsy from patients (psoriasis lesional and non lesional) & control will be kept in
      lysis solution (which contains RNAase inhibitor) for the stability of the parameter to be
      assessed. ERAP-1 gene expression will Research Template 5 Final Version: 8/3/2 016 be
      detected by quantitative real time -PCR, which include RNA extraction, cDNA synthesis & PCR.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: Double (Participant, Investigator)
measure: Estimation of lesional ERAP1 in psoriatic skin
time frame: Maximum 2 years
description: DPCRetection of level of expression of ERAP 1 in lesional skin of psoriasis patients by RT-
measure: Estimation of non lesional ERAP1 in psoriatic skin
time frame: Maximum 2 years
description: Detection of level of expression of ERAP 1 in non lesional skin of psoriasis patients by RT-PCR.
arm group label: cases of psoriasis
arm group type: Experimental
description: group of 25 cases of psoriasis subjected to skin biopsy for detection of lesional and non lesional expression of ERAP1 by RT-PCR
arm group label: normal controls
arm group type: Experimental
description: group of 30 age and sex matched healthy controls o subjected to skin biopsy from normal skin for detection of expression of ERAP1 by RT-PCR
intervention type: Diagnostic Test
intervention name: RT-PCR for ERAP1 detection
description: Reverse transcriptase -Polymerase Chain Reaction for ERAP1 detection
arm group label: cases of psoriasis
arm group label: normal controls
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Kasr El Aini Hospital
investigator full name: Rana F Hilal, MD
investigator title: Lecturer of dermatology
mesh term: Psoriasis