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Genetic Analysis of Pediatric Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03768284
Recruitment Status : Active, not recruiting
First Posted : December 7, 2018
Last Update Posted : November 10, 2021
Sponsor:
Collaborators:
National Psoriasis Foundation
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Amy Paller, Northwestern University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Psoriasis Other: Saliva or buccal sample

Study Design
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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Genetic Analysis of Pediatric Psoriasis
Actual Study Start Date : October 17, 2018
Actual Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 30, 2021

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Psoriasis patients
Patients (of any age) who developed psoriasis before 12 years of age and who have no family history of psoriasis in either parent.
 Other: Saliva or buccal sample
Saliva or buccal sample
Parents of psoriasis patients
Parents of patients who developed psoriasis before 12 years of age
 Other: Saliva or buccal sample
Saliva or buccal sample
Up to third-degree family members with or without psoriasis
Up to third-degree family members (first cousin, grandparent, great-grandparent) with or without psoriasis, if family history is indicated.
 Other: Saliva or buccal sample
Saliva or buccal sample


Outcome Measures
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Primary Outcome Measures :
  1. CARD14 mutations [ Time Frame: one year ]
    The number of pathogenic mutations identified in CARD14 in a pediatric psoriasis cohort


Secondary Outcome Measures :
  1. De novo mutations [ Time Frame: one year ]
    The number of candidate psoriasis genes through the identification of de novo mutations in moderate-to-severe pediatric cases who require systemic intervention.


Biospecimen Retention:   Samples With DNA
Saliva (or buccal swabs in the case of infants) will be obtained for DNA isolation.

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • Patients (of any age) who developed psoriasis before 12 years of age and who have no family history of psoriasis in either parent.
  • Parents of patients who developed psoriasis before 12 years of age
  • Up to third-degree family members (first cousin, grandparent, great-grandparent) with or without psoriasis, if family history is indicated.

Exclusion Criteria:

  • Patients, parents, and other family member unable to give a saliva or buccal swab sample.
  • Patients, parents, and other family member unable to give written informed consent.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03768284


Locations
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United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
National Psoriasis Foundation
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Amy Paller, MD Northwestern University
More Information
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Responsible Party: Amy Paller, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT03768284    
Other Study ID Numbers: 2018-2259
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: November 10, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases