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

August 3, 2017 updated by: King's College London

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

• 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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • Guys and St Thomas NHS Foundation trust and King's College London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Hospital outpatient clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • Fibroscan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 12 months of enrollment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 12 months of enrollment
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.
12-24 months following enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Collaborators

Pfizer

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2012

Primary Completion (Actual)

July 1, 2017

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

May 22, 2014

First Submitted That Met QC Criteria

June 24, 2014

First Posted (Estimate)

June 25, 2014

Study Record Updates

Last Update Posted (Actual)

August 4, 2017

Last Update Submitted That Met QC Criteria

August 3, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WS1851782
  • 11/LO/1236 (Other Identifier: London REC reference number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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