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ProspectIve Cohort psoriASiS fOllow-up (PICASSO)

ProspectIve Cohort psoriASiS fOllow-up (PICASSO)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05122039
Acronym
PICASSO
Enrollment
200
Registered
2021-11-16
Start date
2021-10-20
Completion date
2032-10-19
Last updated
2024-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

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.

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.

Interventions

None listed

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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.10 yearsTo 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

Countries

Belgium

Contacts

Primary ContactTom Hillary, MD
tom.hillary@uzleuven.be+3216337950

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026