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Recruiting NCT05122039

ProspectIve Cohort psoriASiS fOllow-up (PICASSO)

Observational Psoriasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Psoriasis. Basic parameters: 12 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

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.

Primary outcome measures

  • 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. [Time frame: 10 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Belgium · 1 center
  • UZ Leuven — Leuven

Identifiers

NCT: NCT05122039 · s64740

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗