ProspectIve Cohort psoriASiS fOllow-up (PICASSO) (PICASSO)

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.

Study Overview

• Status: Recruiting
• Conditions: Psoriasis

Detailed Description

The PICASSO-project is a prospective register with extensive biobanking in which patients with a recent onset of psoriasis (<3 years) can be enrolled. Participants are followed for a period of 10 years, with scheduled visits every 2.5 years. The same protocol is followed for every visit. The registry captures patient demographics, medical history (personal and family), details of psoriasis treatment (previous and current), physical examination, disease activity scores and PROMs. Some patients (substudy) will undergo ultra-sound to determine carotid intima media thickness. Biobanking in this project encompasses extensive biosampling of multiple tissues. It is not within the scope of this project to administer study medication: patients receive standard of care treatment as prescribed by their physician.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Tom Hillary, MD; Phone Number: +3216337950; Email: tom.hillary@uzleuven.be

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Recruiting
      • UZ Leuven
      • Contact: Tom M Hillary, MD; Phone Number: +3216337950; Email: tom.hillary@uzleuven.be
      • Contact: Tine Vanhoutvin; Phone Number: +3216337865; Email: tine.vanhoutvin@uzleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Tom Hillary, MD, Department of Dermatology, University Hospitals Leuven

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2021
• Primary Completion (Anticipated): October 19, 2032
• Study Completion (Anticipated): October 19, 2032

Study Registration Dates

• First Submitted: November 3, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (Actual): November 16, 2021

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: s64740

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD will be shared. Data on cohort-level will be published.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No