Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-03-11 @ 10:28 PM
Study NCT ID:
NCT03820934
Status:
WITHDRAWN
Last Update Posted:
2020-07-23
First Post:
2019-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FibroScan ® Study: Assessing Liver Fibrosis in Patients Using Methotrexate for Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Per Investigator study was terminated prematurely', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-22', 'studyFirstSubmitDate': '2019-01-15', 'studyFirstSubmitQcDate': '2019-01-28', 'lastUpdatePostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fibrosis Score Correlation', 'timeFrame': '5 years', 'description': 'The correlation between the clinical fibrosis scores generated by the FibroScan® and FibroSURE™ alone and in combination to the METAVIR fibrosis score generated from the histologic review of a liver biopsy performed for the assessment of liver fibrosis in a psoriasis patient who reaches a cumulative methotrexate dose of 1g.'}], 'secondaryOutcomes': [{'measure': 'Fibrosis Score Validity to Liver Biopsy Results', 'timeFrame': '5 years', 'description': 'Determine if the clinical fibrosis scores generated by the FibroScan® and FibroSURE™ alone and in combination can be safely used as alternatives to performing a liver biopsy when screening for liver fibrosis in psoriasis patients who have reached a cumulative methotrexate dose of 1 gram'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Methotrexate', 'FibroScan', 'FibroSure', 'Cirrhosis', 'Fibrosis'], 'conditions': ['Psoriasis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to validate FibroScan and FibroSURE™ as equal or superior alternatives to liver biopsy for the monitoring and detection of methotrexate-induced hepatic fibrosis and cirrhosis in patients with moderate-to-severe psoriasis.', 'detailedDescription': 'The goals of this study are to validate FibroScan and FibroSURE™ as equal or superior alternatives to liver biopsy. The goal is to evaluate the monitoring and detection of methotrexate-induced hepatic fibrosis and cirrhosis in patients with moderate-to-severe psoriasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female greater than or equal to 18 years of age\n* Must have a diagnosis of moderate-to-severe psoriasis\n* Newly starting methotrexate\n\nExclusion Criteria:\n\n* Allergy to methotrexate\n* History of chronic alcohol abuse\n* Diagnosis of liver disease'}, 'identificationModule': {'nctId': 'NCT03820934', 'briefTitle': 'FibroScan ® Study: Assessing Liver Fibrosis in Patients Using Methotrexate for Psoriasis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals Cleveland Medical Center'}, 'officialTitle': 'A Prospective, Validation Study of FibroSURE™ and FibroScan® as Screening, Detection, and Monitoring Alternatives to Liver Biopsy for Methotrexate-induced Hepatic Fibrosis and Cirrhosis in Patients With Psoriasis', 'orgStudyIdInfo': {'id': '12-17-09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients undergoing Fibroscan and Fibrosure', 'description': "Patient's will undergo fibroscan and fibrosure to test their liver for the level of liver fibrosis as measured by these test. The scores from these tests will then be compared to the amount of fibrosis noted on a standard of care liver biopsy.", 'interventionNames': ['Diagnostic Test: Fibroscan and Fibrosure']}], 'interventions': [{'name': 'Fibroscan and Fibrosure', 'type': 'DIAGNOSTIC_TEST', 'description': "Patient's will undergo fibroscan and fibrosure to test their liver for the level of liver fibrosis as measured by these tests. Fibroscan uses vibrations sent through the liver to measure its stiffness and the fibrosure uses laboratory and demographic parameters to create a score associated with a certain level of fibrosis. The scores from these tests will then be compared to the amount of fibrosis noted on a standard of care liver biopsy.", 'armGroupLabels': ['Patients undergoing Fibroscan and Fibrosure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Cleveland Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Neil Korman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Cleveland Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals Cleveland Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Clinical Trials Unit', 'investigatorFullName': 'Neil Korman', 'investigatorAffiliation': 'University Hospitals Cleveland Medical Center'}}}}