ProspectIve Cohort psoriASiS fOllow-up (PICASSO)

Psoriasis Clinical Trial

— PICASSO  

Official title:

ProspectIve Cohort psoriASiS fOllow-up (PICASSO)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05122039
• Other study ID #: s64740
• Status: Recruiting
• Start date: October 20, 2021
• Est. completion date: October 19, 2032

Study information

• Verified date: May 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Tom Hillary, MD
• Phone: +3216337950
• Email: tom.hillary[@]uzleuven.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 19, 2032
• Est. primary completion date: October 19, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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