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An Observational Cohort Study Evaluating Fatty Liver Disease and Liver Fibrosis in Moderate to Severe Psoriasis (CORE)

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ClinicalTrials.gov Identifier: NCT02174367
Recruitment Status : Active, not recruiting
First Posted : June 25, 2014
Last Update Posted : August 4, 2017
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
King's College London

Brief Summary:

• Main objectives and outcome measures.

  1. 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).

  2. Evaluate non-invasive markers of liver fibrosis in the psoriasis population. Namely transient elastography, standard liver function tests and P3NP.
  3. 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

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Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
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


Group/Cohort Intervention/treatment
Psoriasis
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. 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
Serum stored for analysis of non-invasive markers of fibrosis and DNA analysis


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Hospital outpatient clinic
Criteria

Inclusion Criteria:

  • Patients who have given written informed consent
  • Psoriasis patients - chronic plaque-type psoriasis; PASI of 10 or above currently or in past.
  • 18 yrs. of age

Exclusion Criteria:

  • Patients who have not given written informed consent
  • Patients under 18 yrs. of age
  • Patients with a PASI less than 10.
  • Pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02174367


Locations
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United Kingdom
Guys and St Thomas NHS Foundation trust and King's College London
London, United Kingdom, SE1 9RT
Sponsors and Collaborators
King's College London
Pfizer
Investigators
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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

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT02174367     History of Changes
Other Study ID Numbers: WS1851782
11/LO/1236 ( Other Identifier: London REC reference number )
First Posted: June 25, 2014    Key Record Dates
Last Update Posted: August 4, 2017
Last Verified: June 2017
Keywords provided by King's College London:
Chronic plaque psoriasis
Liver fibrosis
Fatty liver disease
Non-alcoholic fatty liver disease
Transient elastography
Fibroscan
Procollagen-3 N-Terminal peptide
Alanine aminotransferase
Liver function tests
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Cirrhosis
Psoriasis
Fibrosis
Pathologic Processes
Skin Diseases, Papulosquamous
Skin Diseases
Digestive System Diseases
Liver Extracts
Hematinics