PsoriasisPICASSONCT05122039
ProspectIve Cohort psoriASiS fOllow-up (PICASSO)
An observational study of Psoriasis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Psoriasis
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Oct 2021to 19 Oct 2032
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Psoriasis patients with disease duration less than three years, aged 12-70 years old at time of inclusion
Who may be able to join
- 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)
Who cannot join
- unwilling or unable to understand and sign the informed consent
- disease duration longer than 3 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, Vlaams-Brabant, 3000
Tom M Hillary, MD, +3216337950, tom.hillary@uzleuven.be
Tine Vanhoutvin, +3216337865, tine.vanhoutvin@uzleuven.be
About this study
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.
Read the 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.
- Conditions
- Psoriasis
- Medical subject headings
- Psoriasis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start20 Oct 2021
- Primary completion19 Oct 2032 (estimated)
- Study completion19 Oct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tom Hillary, MD, Principal investigator, Department of Dermatology, University Hospitals Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05122039
- Sponsor's protocol ID
- s64740
- Acronym
- PICASSO
- Status last verified
- Jun 2024
- First submitted
- 3 Nov 2021
- Last updated
- 1 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared. Data on cohort-level will be published.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ProspectIve Cohort psoriASiS fOllow-up (PICASSO)
- ClinicalTrials.gov ID
- NCT05122039
- Acronym / sponsor ID
- PICASSO / s64740
- Conditions
- Psoriasis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 19 Oct 2032 (estimated)
- Study completion
- 19 Oct 2032 (estimated)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Psoriasis patients with disease duration less than three years, aged 12-70 years old at time of inclusion
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- unwilling or unable to understand and sign the informed consent
- disease duration longer than 3 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Individual participant dataSharing planned: No. No IPD will be shared. Data on cohort-level will be published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tom Hillary, MD principal investigator
Department of Dermatology, University Hospitals Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tom Hillary, MD (+3216337950, tom.hillary@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.