ProspectIve Cohort psoriASiS fOllow-up (PICASSO)

NCT05122039 | Recruiting

• 1 other identifier: s64740
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of the PICASSO-project is to facilitate future psoriasis-research in dermatology. This register biobank will enable us to perform research in the field of metabolomics, mRNA-expression, cardiovascular impact and the microbiome. The final aims are patient stratification, better insight in disease-evolution and improved understanding of markers that predispose to severe disease.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• We hypothesize that metabolic state in early disease (<3 years of disease onset) is linked to and predictive of more severe course of psoriasis after five years.

  To describe the presence/absence of metabolic syndrome (defined by clinical parameters and cut-off levels of associated adipokines (see section 'Background': ref 8-11)) in early disease, and link it to disease severity (eg. mild psoriasis (PASI 0.1-4); moderate psoriasis (PASI 4.1-9.9); severe psoriasis (PASI 10 and above OR receiving systemic treatment/biologics); BSA: mild to moderate (0.1-5%); moderate to severe (5 and above)). It is within the primary endpoint of this project to re-evaluate both MetS- and psoriasis-parameters after 2.5, 5, 7.5 and 10 years

  10 years

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Psoriasis patients with disease duration less than three years, aged 12-70 years old at time of inclusion

You may qualify if:

• Clinical signs of Psoriasis since \>3 years
• adults (70 years old or less) and children (\>12 years old)
• willing and able to understand and sign the informed consent (plus legal representative in case of a minor)

You may not qualify if:

• unwilling or unable to understand and sign the informed consent
• disease duration longer than 3 years

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Patient visits are planned at baseline and after 2.5, 5, 7.5 and 10 years. At all time-points clinical examination and parameters, anamnesis, clinical pictures and questionnaires will be completed. The following samples will be taken at all time-points: * Blood (serum, plasma, DNA) * Skin tape stripping (psoriatic and healthy skin)(mRNA-analysis) * Skin swabs (psoriatic and healthy skin)(skin microbiome) * Nails (DNA-analysis) * Faecal samples (faecal microbiome) * Saliva samples (mRNA-analysis, oral microbiome) * Urine samples (metabolomics) The following examinations are optional: * Skin biopsy * Hair sample * Carotid Intima Media thickness (ultra-sound) * Examination of the oral cavity * Ocular swab (ocular microbiome)

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Tom Hillary, MD

  Department of Dermatology, University Hospitals Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tom Hillary, MD

CONTACT

+3216337950; tom.hillary@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: November 16, 2021
• Study Start: October 20, 2021
• Primary Completion (Estimated): October 19, 2032
• Study Completion (Estimated): October 19, 2032
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)