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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05122039
Other study ID # s64740
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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