xml: <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/NCT05992987</url>
    </required_header>
    <id_info>
      <org_study_id>Soh-Med-23-07-12MS</org_study_id>
      <nct_id>NCT05992987</nct_id>
    </id_info>
    <brief_title>Assessment of Serum Levels of Adenosine Deaminase and Immunoglobulin E in Patients With Chronic Spontaneous Urticaria</brief_title>
    <official_title>Assessment of Serum Levels of Adenosine Deaminase and Immunoglobulin E in Patients With Chronic Spontaneous Urticaria</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sohag University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sohag University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
    </oversight_info>
    <brief_summary>
      <textblock>
        adenosine deaminase activity (ADA) has been reported to be elevated in various diseases such&#xD;
        as psoriasis, acne and juvenile idiopathic arthritis. There is no previous studies that&#xD;
        assessed ADA in chronic spontaneous urticaria (CSU) .&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 15, 2023</start_date>
    <completion_date type="Anticipated">March 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Serum level of adenosine deaminase</measure>
      <time_frame>3 months</time_frame>
      <description>Difference in serum level of adenosine deaminase between CSU group and control group</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Serum level of IgE</measure>
      <time_frame>3 months</time_frame>
      <description>Difference in serum level of IgE between CSU group and control group</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Chronic Spontaneous Urticaria</condition>
    <arm_group>
      <arm_group_label>CSU group</arm_group_label>
      <description>Adult patients complaining of chronic spontaneous urticaria (CSU)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <description>A group of age and sex-matched healthy controls (blood donors).</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Adenosine deaminase serum level</intervention_name>
      <description>Adenosine deaminase will be measured by enzymatic (clorometric / kinetic) method (Diazyme laboratories, San Diego, California, USA).</description>
      <arm_group_label>CSU group</arm_group_label>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>IgE antibodies serum level</intervention_name>
      <description>Level of IgE will be measured by electrochemiluminesence immunoassay (ECLIA, automatic cobase immunoassay, Roche Diagnostics GmbH, Mannheim, USA).</description>
      <arm_group_label>CSU group</arm_group_label>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Settings: Dermatology outpatient clinics and Central Research Lab at Sohag University.&#xD;
  &#xD;
          Study population: The study will include adult patients complaining of CSU and a group of&#xD;
          age and sex-matched healthy controls (blood donors).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  adult patients complaining of CSU and a group of age and sex-matched healthy controls&#xD;
               (blood donors).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnancy and lactation.&#xD;
  &#xD;
            -  Patients with systemic diseases, especially those with autoimmune diseases and&#xD;
               infections.&#xD;
  &#xD;
            -  Patients with skin diseases.&#xD;
  &#xD;
            -  Patients on medications such as antibiotics, nonsteroidal anti-inflammatory drugs,&#xD;
               angiotensin-converting enzyme inhibitors, anticonvulsants, penicillin, and combined&#xD;
               oral contraceptives.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Ramadan Saleh, MD</last_name>
      <role>Study Director</role>
      <affiliation>Sohag University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ahmed M Ahmed, M.B.B.Ch</last_name>
      <phone>+201093593974</phone>
      <email>Dr.ahmed.elsheikh94@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ramadan Saleh, MD</last_name>
      <phone>+201005423054</phone>
      <email>salehr2010@yahoo.com</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sohag University</investigator_affiliation>
      <investigator_full_name>Ahmed Mohamed Ahmed</investigator_full_name>
      <investigator_title>Resident physician at Dermatology department, Sohag University</investigator_title>
    </responsible_party>
    <keyword>chronic spontaneous urticaria</keyword>
    <keyword>adenosine deaminase</keyword>
    <keyword>immunoglobulin E</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Urticaria</mesh_term>
      <mesh_term>Chronic Urticaria</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Adenosine</mesh_term>
      <mesh_term>Antibodies</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>IPD will be shared upon request to the study director</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>Data will become available after study due for unlimited period of time.</ipd_time_frame>
      <ipd_access_criteria>IPD will be shared upon request by the study director. Patients' names will be anonymous.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05992987
  org study id: Soh-Med-23-07-12MS
  nct id: NCT05992987
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  adenosine deaminase activity (ADA) has been reported to be elevated in various diseases such
        as psoriasis, acne and juvenile idiopathic arthritis. There is no previous studies that
        assessed ADA in chronic spontaneous urticaria (CSU) .
  observational model: Case-Control
  time perspective: Cross-Sectional
  measure: Serum level of adenosine deaminase
  time frame: 3 months
  description: Difference in serum level of adenosine deaminase between CSU group and control group
  measure: Serum level of IgE
  time frame: 3 months
  description: Difference in serum level of IgE between CSU group and control group
  arm group label: CSU group
  description: Adult patients complaining of chronic spontaneous urticaria (CSU)
  arm group label: Control group
  description: A group of age and sex-matched healthy controls (blood donors).
  intervention type: Diagnostic Test
  intervention name: Adenosine deaminase serum level
  description: Adenosine deaminase will be measured by enzymatic (clorometric / kinetic) method (Diazyme laboratories, San Diego, California, USA).
  arm group label: CSU group
  arm group label: Control group
  intervention type: Diagnostic Test
  intervention name: IgE antibodies serum level
  description: Level of IgE will be measured by electrochemiluminesence immunoassay (ECLIA, automatic cobase immunoassay, Roche Diagnostics GmbH, Mannheim, USA).
  arm group label: CSU group
  arm group label: Control group
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Ramadan Saleh, MD
  role: Study Director
  affiliation: Sohag University
  last name: Ahmed M Ahmed, M.B.B.Ch
  phone: +201093593974
  email: Dr.ahmed.elsheikh94@gmail.com
  last name: Ramadan Saleh, MD
  phone: +201005423054
  email: salehr2010@yahoo.com
  responsible party type: Principal Investigator
  investigator affiliation: Sohag University
  investigator full name: Ahmed Mohamed Ahmed
  investigator title: Resident physician at Dermatology department, Sohag University
  mesh term: Urticaria
  mesh term: Chronic Urticaria
  mesh term: Adenosine
  mesh term: Antibodies
  sharing ipd: Yes
  ipd description: IPD will be shared upon request to the study director
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: Data will become available after study due for unlimited period of time.
  ipd access criteria: IPD will be shared upon request by the study director. Patients' names will be anonymous.