Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-01-22 @ 8:51 AM
Study NCT ID:
NCT00575133
Status:
RECRUITING
Last Update Posted:
2012-02-24
First Post:
2007-11-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Cohort Study in Patients With NAFLD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Liver biopsy'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-02-23', 'studyFirstSubmitDate': '2007-11-26', 'studyFirstSubmitQcDate': '2007-12-17', 'lastUpdatePostDateStruct': {'date': '2012-02-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease regression/progression', 'timeFrame': '20 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Non-alcoholic Fatty Liver Disease']}, 'descriptionModule': {'briefSummary': 'To assess the importance of intracellular signalling pathways and its deregulation in adiposity and diabetes-related insulin resistance, liver tissue samples of patients suffering from non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH)will be analyzed prospectively from a liver tissue bank.', 'detailedDescription': 'Patients with suspected fatty liver disease will be screened (and excluded in the presence) of alternative clinical condition associated with NAFLD (see exclusion criteria). Of all patients fulfilling inclusion criteria, relevant baseline characteristics (incl. epidemiological, physiological and biochemical data) will be obtained. In addition, radiological examination will be performed using sonography and fibroscan to assess non-invasively the individual extent of hepatic fat deposition, liver stiffness (fibrosis) and amount of visceral fat mass. In case of high clinical, laboratory and radiological suspicion for NAFLD, a diagnostic liver biopsy will be performed. A part of the liver tissue is used for histological confirmation of NAFLD and subsequent grading and staging according established criteria. Parts of the remaining liver tissue will be stored for later molecular and histological analysis. In addition, several serum samples are collected of patients and stored for future analysis. All patients will be followed up annually (incl. physical examination, metabolic characterisation, clinical chemistry and liver sonography) and additional serum samples will be collected for future analysis. Liver biopsy is not repeated after defined time period, but in case of clinical evidence for disease progression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with non-alcoholic fatty liver disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patients with histologically confirmed fatty liver disease\n\nExclusion criteria:\n\n* History of significant alcohol consumption\n* Viral hepatitis\n* Autoimmune hepatitis\n* Metabolic diseases (e.g. hemochromatosis, M. Wilson, alpha 1-antitrypsin deficiency)\n* Hepatotoxic medication (e.g. amiodarone).'}, 'identificationModule': {'nctId': 'NCT00575133', 'briefTitle': 'Prospective Cohort Study in Patients With NAFLD', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Multicentric, Prospective, Non-interventional, Long-term Cohort Study in Patients With Non-alcoholic Fatty Liver Disease (NAFLD)', 'orgStudyIdInfo': {'id': 'EK-1450'}}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Oliver Tschopp, MD', 'role': 'CONTACT', 'email': 'oliver.tschopp@usz.ch'}], 'facility': 'University Hospital Zurich, Endocrinology and Diabetology', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Oliver Tschopp', 'role': 'CONTACT', 'email': 'oliver.tschopp@usz.ch', 'phone': '+41 (0)44 255 11 11'}, {'name': 'Giatgen Spinas, Professor, MD', 'role': 'CONTACT', 'email': 'giatgen.spinas@usz.ch'}], 'overallOfficials': [{'name': 'Giatgen Spinas, Prof. MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Zurich, Endocrinology and Diabetology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}