ProspectIve Cohort psoriASiS fOllow-up (PICASSO)

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 12 Years - 70 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05122039
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Universitaire Ziekenhuizen KU Leuven
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Tom Hillary, MD
Principal Investigator Affiliation Department of Dermatology, University Hospitals Leuven
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Belgium
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

UZ Leuven, Leuven, Vlaams-Brabant, Belgium

Status

Recruiting

Address

UZ Leuven

Leuven, Vlaams-Brabant, 3000

Site Contact

Tom M Hillary, MD

tom.hillary@uzleuven.be

+3216337950

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