Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-02-05 @ 3:35 AM
Study NCT ID:
NCT02174367
Status:
UNKNOWN
Last Update Posted:
2017-08-04
First Post:
2014-05-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Cohort Study Evaluating Fatty Liver Disease and Liver Fibrosis in Moderate to Severe Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum stored for analysis of non-invasive markers of fibrosis and DNA analysis'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-03', 'studyFirstSubmitDate': '2014-05-22', 'studyFirstSubmitQcDate': '2014-06-24', 'lastUpdatePostDateStruct': {'date': '2017-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Sensitivity, specificity, and likelihood ratios of noninvasive tests of liver fibrosis', 'timeFrame': 'Within 12 months of enrollment', 'description': '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.'}, {'measure': 'Response to treatment measured by PASI and PGA scores', 'timeFrame': '12-24 months following enrollment', 'description': '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.'}], 'primaryOutcomes': [{'measure': 'Number of participants with liver fibrosis.', 'timeFrame': '12 months after enrollment', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Number of participants with fatty liver disease diagnosed by ultrasound', 'timeFrame': 'Within 12 months of enrollment', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['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'], 'conditions': ['Psoriasis Chronic', 'Liver Fibrosis', 'Fatty Liver', 'Non-alcoholic Fatty Liver Disease']}, 'referencesModule': {'references': [{'pmid': '24606161', 'type': 'BACKGROUND', 'citation': 'Maybury CM, Jabbar-Lopez ZK, Wong T, Dhillon AP, Barker JN, Smith CH. Methotrexate and liver fibrosis in people with psoriasis: a systematic review of observational studies. Br J Dermatol. 2014 Jul;171(1):17-29. doi: 10.1111/bjd.12941. Epub 2014 Jul 15.'}, {'pmid': '24588075', 'type': 'BACKGROUND', 'citation': 'Maybury CM, Samarasekera E, Douiri A, Barker JN, Smith CH. Diagnostic accuracy of noninvasive markers of liver fibrosis in patients with psoriasis taking methotrexate: a systematic review and meta-analysis. Br J Dermatol. 2014 Jun;170(6):1237-47. doi: 10.1111/bjd.12905.'}, {'pmid': '24715130', 'type': 'BACKGROUND', 'citation': 'Samarasekera EJ, Smith CH; National Institute of Health and Care Excellence; Royal College of Physicians. Psoriasis: guidance on assessment and referral. Clin Med (Lond). 2014 Apr;14(2):178-82. doi: 10.7861/clinmedicine.14-2-178.'}, {'pmid': '16916825', 'type': 'BACKGROUND', 'citation': 'Smith CH, Barker JN. Psoriasis and its management. BMJ. 2006 Aug 19;333(7564):380-4. doi: 10.1136/bmj.333.7564.380. No abstract available.'}, {'pmid': '19641206', 'type': 'BACKGROUND', 'citation': 'Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med. 2009 Jul 30;361(5):496-509. doi: 10.1056/NEJMra0804595. No abstract available.'}, {'pmid': '20080817', 'type': 'BACKGROUND', 'citation': 'Boehncke WH, Boehncke S, Schon MP. Managing comorbid disease in patients with psoriasis. BMJ. 2010 Jan 15;340:b5666. doi: 10.1136/bmj.b5666. No abstract available.'}, {'pmid': '20662837', 'type': 'BACKGROUND', 'citation': 'Fonia A, Jackson K, Lereun C, Grant DM, Barker JN, Smith CH. A retrospective cohort study of the impact of biologic therapy initiation on medical resource use and costs in patients with moderate to severe psoriasis. Br J Dermatol. 2010 Oct;163(4):807-16. doi: 10.1111/j.1365-2133.2010.09944.x.'}, {'pmid': '31166567', 'type': 'DERIVED', 'citation': 'Maybury CM, Porter HF, Kloczko E, Duckworth M, Cotton A, Thornberry K, Dew T, Crook M, Natas S, Miquel R, Lewis CM, Wong T, Smith CH, Barker JN. Prevalence of Advanced Liver Fibrosis in Patients With Severe Psoriasis. JAMA Dermatol. 2019 Sep 1;155(9):1028-1032. doi: 10.1001/jamadermatol.2019.0721.'}]}, 'descriptionModule': {'briefSummary': '• Main objectives and outcome measures.\n\n1. Establish prevalence of and factors contributing to fatty liver disease and liver fibrosis in patients with psoriasis.\n\n 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).\n2. Evaluate non-invasive markers of liver fibrosis in the psoriasis population. Namely transient elastography, standard liver function tests and P3NP.\n3. Evaluate the impact of psoriasis disease severity and comorbidities including metabolic syndrome on response to treatment in patients with psoriasis.\n\nData 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).\n\n* Study population: 380 patients with moderate to severe psoriasis will be prospectively recruited to the study.\n* Chief investigator: Professor Jonathan Barker. Co-investigator: Professor Catherine Smith\n* Sponsor/funding organization: Pfizer and Biomedical Research Centre (BRC) at Guys and St Thomas Hospitals Trust'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Hospital outpatient clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have given written informed consent\n* Psoriasis patients - chronic plaque-type psoriasis; PASI of 10 or above currently or in past.\n* 18 yrs. of age\n\nExclusion Criteria:\n\n* Patients who have not given written informed consent\n* Patients under 18 yrs. of age\n* Patients with a PASI less than 10.\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT02174367', 'acronym': 'CORE', 'briefTitle': 'An Observational Cohort Study Evaluating Fatty Liver Disease and Liver Fibrosis in Moderate to Severe Psoriasis', 'organization': {'class': 'OTHER', 'fullName': "King's College London"}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'WS1851782'}, 'secondaryIdInfos': [{'id': '11/LO/1236', 'type': 'OTHER', 'domain': 'London REC reference number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Psoriasis', 'description': '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.', 'interventionNames': ['Device: Transient elastography']}], 'interventions': [{'name': 'Transient elastography', 'type': 'DEVICE', 'otherNames': ['Fibroscan'], 'description': 'a noninvasive tool for measuring liver stiffness as a predictor of liver fibrosis', 'armGroupLabels': ['Psoriasis']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE1 9RT', 'city': 'London', 'country': 'United Kingdom', 'facility': "Guys and St Thomas NHS Foundation trust and King's College London", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Jonathan N Barker, BSC MD FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "King's College London"}, {'name': 'Catherine H Smith, MD FRCP', 'role': 'STUDY_DIRECTOR', 'affiliation': "Guys and St Thomas' Hospitals Foundation Trust and King's College London"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "King's College London", 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}