PsoriasisNCT03768284
Genetic Analysis of Pediatric Psoriasis
An observational study of Psoriasis, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Psoriasis
- What is being tested?
- Saliva or buccal sample
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2018to 30 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
About this study
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.
- Conditions
- Psoriasis
- Being tested
- Saliva or buccal sample
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saliva or buccal sampleOther
Saliva or buccal sample
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Saliva or buccal sample | |
| Parents of psoriasis patients | Parents of patients who developed psoriasis before 12 years of age Receives: 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. Receives: Other: Saliva or buccal sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
CARD14 mutations
The number of pathogenic mutations identified in CARD14 in a pediatric psoriasis cohort
Measured: one year
Secondary outcomes (1)
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start17 Oct 2018
- Primary completion30 Jun 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Psoriasis Foundation, Icahn School of Medicine at Mount Sinai
- Responsible party
- Principal investigator, Amy Paller, Northwestern University
- Investigators
- Amy Paller, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03768284
- Sponsor's protocol ID
- 2018-2259
- Status last verified
- Apr 2022
- First submitted
- 5 Dec 2018
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Analysis of Pediatric Psoriasis
- ClinicalTrials.gov ID
- NCT03768284
- Acronym / sponsor ID
- 2018-2259
- Conditions
- Psoriasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Psoriasis Foundation, Icahn School of Medicine at Mount Sinai
- Study start
- 17 Oct 2018 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 7 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Psoriasis patients | – | Other: Saliva or buccal samplePatients (of any age) who developed psoriasis before 12 years of age and who have no family history of psoriasis in either parent. |
| Parents of psoriasis patients | – | Other: Saliva or buccal sampleParents of patients who developed psoriasis before 12 years of age |
| Up to third-degree family members with or without psoriasis | – | Other: Saliva or buccal sampleUp to third-degree family members (first cousin, grandparent, great-grandparent) with or without psoriasis, if family history is indicated. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saliva or buccal sampleSaliva or buccal sample | Other | Parents of psoriasis patients, Psoriasis patients, Up to third-degree family members with or without psoriasis |
Primary outcome
CARD14 mutations
Time frame: one year
The number of pathogenic mutations identified in CARD14 in a pediatric psoriasis cohort
1 secondary outcome
De novo mutations
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Paller, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CARD14 mutations (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.