NCT03768284

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 17, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 7, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

2.7 years

First QC Date

December 5, 2018

Last Update Submit

April 19, 2022

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

  • CARD14 mutations

    The number of pathogenic mutations identified in CARD14 in a pediatric psoriasis cohort

    one year

Secondary Outcomes (1)

  • De novo mutations

    one year

Study Arms (3)

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

Parents of psoriasis patients

Parents of patients who developed psoriasis before 12 years of age

Other: 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

Interventions

Saliva or buccal sampleOTHER

Saliva or buccal sample

Parents of psoriasis patientsPsoriasis patientsUp to third-degree family members with or without psoriasis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva (or buccal swabs in the case of infants) will be obtained for DNA isolation.

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Amy Paller, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 5, 2018

First Posted

December 7, 2018

Study Start

October 17, 2018

Primary Completion

June 30, 2021

Study Completion

December 30, 2021

Last Updated

April 20, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)