<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/NCT03768284</url>
  </required_header>
  <id_info>
    <org_study_id>2018-2259</org_study_id>
    <nct_id>NCT03768284</nct_id>
  </id_info>
  <brief_title>Genetic Analysis of Pediatric Psoriasis</brief_title>
  <official_title>Genetic Analysis of Pediatric Psoriasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Psoriasis Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Northwestern University</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>
      This study will ascertain approximately 150 subjects, which will include pediatric psoriasis&#xD;
      patients diagnosed before age 12, parents not affected by psoriasis, and if a family history&#xD;
      is indicated, up to third-degree family members. Saliva (or buccal swabs in the case of&#xD;
      infants) will be obtained for DNA isolation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 17, 2018</start_date>
  <completion_date type="Actual">December 30, 2021</completion_date>
  <primary_completion_date type="Actual">June 30, 2021</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>CARD14 mutations</measure>
    <time_frame>one year</time_frame>
    <description>The number of pathogenic mutations identified in CARD14 in a pediatric psoriasis cohort</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>De novo mutations</measure>
    <time_frame>one year</time_frame>
    <description>The number of candidate psoriasis genes through the identification of de novo mutations in moderate-to-severe pediatric cases who require systemic intervention.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">86</enrollment>
  <condition>Psoriasis</condition>
  <arm_group>
    <arm_group_label>Psoriasis patients</arm_group_label>
    <description>Patients (of any age) who developed psoriasis before 12 years of age and who have no family history of psoriasis in either parent.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Parents of psoriasis patients</arm_group_label>
    <description>Parents of patients who developed psoriasis before 12 years of age</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Up to third-degree family members with or without psoriasis</arm_group_label>
    <description>Up to third-degree family members (first cousin, grandparent, great-grandparent) with or without psoriasis, if family history is indicated.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Saliva or buccal sample</intervention_name>
    <description>Saliva or buccal sample</description>
    <arm_group_label>Parents of psoriasis patients</arm_group_label>
    <arm_group_label>Psoriasis patients</arm_group_label>
    <arm_group_label>Up to third-degree family members with or without psoriasis</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Saliva (or buccal swabs in the case of infants) will be obtained for DNA isolation.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        This study will ascertain approximately 150 subjects, which will include pediatric&#xD;
        psoriasis patients diagnosed before age 12, parents not affected by psoriasis, and if a&#xD;
        family history is indicated, up to third-degree family members.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients (of any age) who developed psoriasis before 12 years of age and who have no&#xD;
             family history of psoriasis in either parent.&#xD;
&#xD;
          -  Parents of patients who developed psoriasis before 12 years of age&#xD;
&#xD;
          -  Up to third-degree family members (first cousin, grandparent, great-grandparent) with&#xD;
             or without psoriasis, if family history is indicated.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients, parents, and other family member unable to give a saliva or buccal swab&#xD;
             sample.&#xD;
&#xD;
          -  Patients, parents, and other family member unable to give written informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amy Paller, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ann &amp; Robert H. Lurie Children's Hospital of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</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 7, 2018</study_first_posted>
  <last_update_submitted>April 19, 2022</last_update_submitted>
  <last_update_submitted_qc>April 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Amy Paller</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</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/NCT03768284
org study id: 2018-2259
nct id: NCT03768284
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will ascertain approximately 150 subjects, which will include pediatric psoriasis
      patients diagnosed before age 12, parents not affected by psoriasis, and if a family history
      is indicated, up to third-degree family members. Saliva (or buccal swabs in the case of
      infants) will be obtained for DNA isolation.
observational model: Case-Control
time perspective: Cross-Sectional
measure: CARD14 mutations
time frame: one year
description: The number of pathogenic mutations identified in CARD14 in a pediatric psoriasis cohort
measure: De novo mutations
time frame: one year
description: The number of candidate psoriasis genes through the identification of de novo mutations in moderate-to-severe pediatric cases who require systemic intervention.
arm group label: Psoriasis patients
description: Patients (of any age) who developed psoriasis before 12 years of age and who have no family history of psoriasis in either parent.
arm group label: Parents of psoriasis patients
description: Parents of patients who developed psoriasis before 12 years of age
arm group label: Up to third-degree family members with or without psoriasis
description: Up to third-degree family members (first cousin, grandparent, great-grandparent) with or without psoriasis, if family history is indicated.
intervention type: Other
intervention name: Saliva or buccal sample
description: Saliva or buccal sample
arm group label: Parents of psoriasis patients
arm group label: Psoriasis patients
arm group label: Up to third-degree family members with or without psoriasis
Saliva (or buccal swabs in the case of infants) will be obtained for DNA isolation.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Amy Paller, MD
role: Principal Investigator
affiliation: Northwestern University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Amy Paller
investigator title: Principal Investigator
mesh term: Psoriasis
sharing ipd: No