An Observational Cohort Study Evaluating Fatty Liver Disease and Liver Fibrosis in Moderate to Severe Psoriasis (CORE)
|ClinicalTrials.gov Identifier: NCT02174367|
Recruitment Status : Active, not recruiting
First Posted : June 25, 2014
Last Update Posted : August 4, 2017
• Main objectives and outcome measures.
Establish prevalence of and factors contributing to fatty liver disease and liver fibrosis in patients with psoriasis.
Fatty liver disease diagnosed via ultrasound. Liver fibrosis diagnosed by liver biopsy or non-invasive tests of fibrosis including transient elastography, ultrasound, serum markers of fibrosis including procollagen-3-N-terminal peptide (P3NP).
- Evaluate non-invasive markers of liver fibrosis in the psoriasis population. Namely transient elastography, standard liver function tests and P3NP.
- Evaluate the impact of psoriasis disease severity and comorbidities including metabolic syndrome on response to treatment in patients with psoriasis.
Data on co-morbid disease collected through questionnaires and review of medical records. Response to treatment assessed using psoriasis area and severity index (PASI) physician global assessment (PGA) and dermatology life quality index (DLQI).
- Study population: 380 patients with moderate to severe psoriasis will be prospectively recruited to the study.
- Chief investigator: Professor Jonathan Barker. Co-investigator: Professor Catherine Smith
- Sponsor/funding organization: Pfizer and Biomedical Research Centre (BRC) at Guys and St Thomas Hospitals Trust
|Condition or disease||Intervention/treatment|
|Psoriasis Chronic Liver Fibrosis Fatty Liver Non-alcoholic Fatty Liver Disease||Device: Transient elastography|
|Study Type :||Observational|
|Actual Enrollment :||400 participants|
|Official Title:||An Observational Cohort Study to Evaluate Factors Affecting Prevalence of Fatty Liver Disease and Fibrosis and Factors Affecting Response to Treatment in Patients With Psoriasis|
|Actual Study Start Date :||November 2012|
|Actual Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||July 2021|
Patients with moderate to sever psoriasis attending a tertiary referral center. patients will be evaluated with a questionnaire, measurement of height,weight, waist circumference, fasting bloods, abdominal ultrasound and transient elastography.
Device: Transient elastography
a noninvasive tool for measuring liver stiffness as a predictor of liver fibrosis
Other Name: Fibroscan
- Number of participants with liver fibrosis. [ Time Frame: 12 months after enrollment ]Liver fibrosis will be assessed by transient elastography and the use of standard liver function tests and other serum markers of fibrosis including P3NP. In a minority of cases fibrosis will be diagnosed by liver biopsy and evaluation of histology. Risk factors for the development of fibrosis including metabolic syndrome, alcohol and methotrexate use will be evaluated.
- Number of participants with fatty liver disease diagnosed by ultrasound [ Time Frame: Within 12 months of enrollment ]Fatty liver disease will be defined by the presence or absence of fatty changes on abdominal ultrasound. Risk factors for the development of fatty liver disease including abdominal obesity, diabetes, and alcohol use will be evaluated.
- Sensitivity, specificity, and likelihood ratios of noninvasive tests of liver fibrosis [ Time Frame: Within 12 months of enrollment ]The performance of non-invasive markers of fibrosis including standard liver function tests, P3NP, transient elastography and abdominal ultrasound will be assessed in this cohort of patients with chronic plaque psoriasis.
- Response to treatment measured by PASI and PGA scores [ Time Frame: 12-24 months following enrollment ]Response to treatment will be measure by physician global assessment (PGA) PASI and DLQI. Factors assessed include demographic data, psoriasis disease history, co-morbid disease and family history assessed by questionnaire. Lipid and glycaemic status assessed by fasting bloods.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02174367
|Guys and St Thomas NHS Foundation trust and King's College London|
|London, United Kingdom, SE1 9RT|
|Principal Investigator:||Jonathan N Barker, BSC MD FRCP||King's College London|
|Study Director:||Catherine H Smith, MD FRCP||Guys and St Thomas' Hospitals Foundation Trust and King's College London|