Genetic Analysis of Pediatric Psoriasis

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Other: Saliva or buccal sample

• Study Type: Observational
• Enrollment (Actual): 86

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Ann & Robert H. Lurie Children's Hospital of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CARD14 mutations	The number of pathogenic mutations identified in CARD14 in a pediatric psoriasis cohort	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
De novo mutations	The number of candidate psoriasis genes through the identification of de novo mutations in moderate-to-severe pediatric cases who require systemic intervention.	one year

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Icahn School of Medicine at Mount Sinai; National Psoriasis Foundation

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2018
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: December 5, 2018
• First Submitted That Met QC Criteria: December 5, 2018
• First Posted (Actual): December 7, 2018

Study Record Updates

• Last Update Posted (Actual): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: 2018-2259

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No