Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2026-01-20 @ 6:16 PM
Study NCT ID:
NCT02603666
Status:
COMPLETED
Last Update Posted:
2016-12-30
First Post:
2015-05-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Elastography of the Liver in Cystic Fibrosis Patients. Diagnostic and Prognostic Aspects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054459', 'term': 'Elasticity Imaging Techniques'}], 'ancestors': [{'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ferenc.karpati@karolinska.se', 'phone': '+46858580000', 'title': 'Ferenc Karpati M.D., Ph.D., Senior Consultant', 'phoneExt': '81656', 'organization': 'Karolinska University Hospital, Huddinge, 141 86 Stockholm'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '2 years', 'eventGroups': [{'id': 'EG000', 'title': 'Elastography', 'description': "Fibroscan elastography device for evaluation of liver disease in CF patients.\n\nFibroscan: Ultrasound by specific wavelength developed for elastography, repeated measures according to the manufacturer's instructions.", 'otherNumAtRisk': 130, 'otherNumAffected': 0, 'seriousNumAtRisk': 130, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Elastographic Value in kPa Measured by Fibroscan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Elastography', 'description': "Fibroscan elastography device for evaluation of liver disease in CF patients.\n\nFibroscan: Ultrasound by specific wavelength developed for elastography, repeated measures according to the manufacturer's instructions."}], 'classes': [{'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within 28 days in connection with their annual evaluation at a single point of time', 'description': 'Elastographic values given in kPa by Fibroscan. All patients undergo elastographic measurement of the liver and ultrasound of the liver. The grade of fibrosis is to be established by setting the cut-off for cystic fibrosis patients.', 'unitOfMeasure': 'kPa', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Elastography', 'description': "Fibroscan elastography device for evaluation of liver disease in CF patients.\n\nFibroscan: Ultrasound by specific wavelength developed for elastography, repeated measures according to the manufacturer's instructions."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '130'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '130'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Outpatient department, between 04/Feb/2012 and 04/Apr/2014'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Elastography', 'description': "Fibroscan elastography device for evaluation of liver disease in CF patients.\n\nFibroscan: Ultrasound by specific wavelength developed for elastography, repeated measures according to the manufacturer's instructions."}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '57', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '71', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '73', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '57', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Sweden', 'categories': [{'measurements': [{'value': '130', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Stockholm Cystic Fibrosis Center, Sweden Prospective inclusion', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2015-05-04', 'resultsFirstSubmitDate': '2016-09-06', 'studyFirstSubmitQcDate': '2015-11-10', 'lastUpdatePostDateStruct': {'date': '2016-12-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-11-01', 'studyFirstPostDateStruct': {'date': '2015-11-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Elastographic Value in kPa Measured by Fibroscan', 'timeFrame': 'Within 28 days in connection with their annual evaluation at a single point of time', 'description': 'Elastographic values given in kPa by Fibroscan. All patients undergo elastographic measurement of the liver and ultrasound of the liver. The grade of fibrosis is to be established by setting the cut-off for cystic fibrosis patients.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cystic fibrosis', 'elastography', 'liver biopsy'], 'conditions': ['Cystic Fibrosis', 'Liver Fibrosis']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to find CF patients at risk for cystic fibrosis related liver disease (CFLD). Comparison of ultrasound by two modalities and biochemical markers with histological evaluation of liver biopsy if present.', 'detailedDescription': 'There are 209 CF patients attending Stockholm Cystic Fibrosis Center (January 2010). All up till 15 years of age are screened for liver disease annually by ultrasound (US) and also by biochemical markers. Ultrasound is performed every third year over 15 years of age in patients without CFLD, while all of them with diagnosed CFLD are continued to be investigated annually. Biochemical markers are controlled at least once every year in all CF patients. Elastography of the liver will be planned together with the investigations of the annual follow up, in an optimal clinical status. If either US or elastography of the liver indicates liver disease or progress of the already existing pathological changes, a liver biopsy will be performed according to routine procedure at Stockholm CF Centre. Also, historical data of liver biopsies and biochemical investigations will be considered in the study.\n\nElastography of the liver will be performed by Fibroscan device, with transducers for children and adults, respectively.\n\nClinical importance Liver US investigations in CF patients have important implications but are difficult to standardize in a routine clinical setting. Elastography may have an advantage in the evaluation of early fibrosis with clinical importance in pursuing diagnostics and intensifying treatment. A significant group (up to 25 %) of CF patients may be helped by this novel method. Including histological data, accuracy of elastography in CF patients may be improved. Further details of the importance of fatty acid status in CF may be elucidated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Verified cystic fibrosis\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT02603666', 'briefTitle': 'Elastography of the Liver in Cystic Fibrosis Patients. Diagnostic and Prognostic Aspects', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska University Hospital'}, 'officialTitle': 'Elastography of the Liver in Cystic Fibrosis Patients. Diagnostic and Prognostic Aspects', 'orgStudyIdInfo': {'id': '2010/1957/31/3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Elastography', 'description': 'Fibroscan elastography device for evaluation of liver disease in CF patients.', 'interventionNames': ['Device: Fibroscan']}], 'interventions': [{'name': 'Fibroscan', 'type': 'DEVICE', 'otherNames': ['Elastography'], 'description': "Ultrasound by specific wavelength developed for elastography, repeated measures according to the manufacturer's instructions.", 'armGroupLabels': ['Elastography']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ferenc Karpati, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stockholm CF Center, Karolinska University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Karolinska Institutet', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Ferenc Karpati', 'investigatorAffiliation': 'Karolinska University Hospital'}}}}