Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT05486767
Status:
UNKNOWN
Last Update Posted:
2022-08-05
First Post:
2022-08-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Screening of Liver Fibrosis in Adults Without Known Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'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'}, {'id': 'D005234', 'term': 'Fatty Liver'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Stool sample for microbiome analysis by 16S RNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-08-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-04', 'studyFirstSubmitDate': '2022-08-02', 'studyFirstSubmitQcDate': '2022-08-02', 'lastUpdatePostDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Gut microbiome dysbiosis', 'timeFrame': 'August, 2022 - September, 2023', 'description': 'Dysbiosis will be determined based on the alpha and beta diversity, followed by a the taxonomic analysis'}], 'primaryOutcomes': [{'measure': 'Liver fibrosis', 'timeFrame': 'August, 2022 - to September 2023', 'description': 'The amount of fibrous tissue in the liver according to non-invasive tests'}], 'secondaryOutcomes': [{'measure': 'Non-alcoholic fatty liver disease', 'timeFrame': 'August, 2022 - September, 2023', 'description': 'The amount of fat in the liver parenchyma by the non-invasive tests CAP and FLI'}, {'measure': 'Alcohol associated liver disease', 'timeFrame': 'August, 2022 - September, 2023', 'description': 'Liver disease plus AUDIT score testimonyijng to the harmful alcohol use'}, {'measure': 'Body mass index', 'timeFrame': 'August, 2022 - September, 2023', 'description': 'As calculated from height and weight (together with waist-to-hip ratio)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Liver fibrosis', 'Screening', 'Non-alcoholic fatty liver disease', 'Alcohol associated liver disease'], 'conditions': ['Liver Fibrosis']}, 'referencesModule': {'references': [{'pmid': '35854275', 'type': 'BACKGROUND', 'citation': 'Graupera I, Thiele M, Ma AT, Serra-Burriel M, Pich J, Fabrellas N, Caballeria L, de Knegt RJ, Grgurevic I, Reichert M, Roulot D, Schattenberg JM, Pericas JM, Angeli P, Tsochatzis EA, Guha IN, Garcia-Retortillo M, Morillas RM, Hernandez R, Hoyo J, Fuentes M, Madir A, Juanola A, Soria A, Juan M, Carol M, Diaz A, Detlefsen S, Toran P, Pera G, Fournier C, Llorca A, Newsome PN, Manns M, de Koning HJ, Serra-Burriel F, Cucchietti F, Arslanow A, Korenjak M, van Kleef L, Falco JL, Kamath PS, Karlsen TH, Castera L, Lammert F, Krag A, Gines P; LiverScreen Consortium investigators. LiverScreen project: study protocol for screening for liver fibrosis in the general population in European countries. BMC Public Health. 2022 Jul 19;22(1):1385. doi: 10.1186/s12889-022-13724-6.'}]}, 'descriptionModule': {'briefSummary': 'SIRIUS is the "serious" response to the prevalence of liver cirrhosis in Slovakia. We plan to screen adult Slovaks without acute or life-threatening comorbidity and without known liver disease (except from non-alcoholic fatty liver disease) for liver fibrosis by transient elastography (in community) or FIB-4 score (in outpatient clinics).', 'detailedDescription': 'According to the Lancet Gastroenterology and Hepatology, Slovakia ranks at the top of the prevalence of liver cirrhosis in the world. Moreover, liver diseases are the leading cause of death in the age-group of 25 - 50 years-old. SIRIUS is the response conceived by the governing board of the Slovak society of hepatology with two main aims: to screen for liver fibrosis and to spread the largely unknown information in community, and primary-care sector.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We will approach adults of any ethnicity and gender in a stable health-status without any diseases or with a chronic extra-hepatic disease/diseases which are at the time of exam compensated and under control for more than 2 months; any medication is acceptable. Primarily, we are interested in patients without any known history of registered liver disease, but patients with steatosis without known fibrosis or cirrhosis will be enrolled.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult, written informed consent\n\nExclusion Criteria:\n\n* unable to provide sufficient reliable information for any reason\n* withdrawal of the consent, anytime\n* acute illness (e.g. febrile, drunk, on antibiotics, trauma, myocardial infarction \\< 2 months, operated on \\< 2 months, other)\n* chronic disease interfering with the endpoint (malignancy \\< 2 years; decompensated chronic disease such as chronic heart disease with dyspnea New York heart Association NYHA 2+, Chronic obstructive pulmonary disease COPD GOLD B+, other)\n* chronic liver disease other than non-alcoholic fatty liver disease without previous diagnosis of fibrosis'}, 'identificationModule': {'nctId': 'NCT05486767', 'acronym': 'SIRIUS', 'briefTitle': 'Screening of Liver Fibrosis in Adults Without Known Liver Disease', 'organization': {'class': 'OTHER', 'fullName': 'F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica'}, 'officialTitle': 'Screening of Liver Fibrosis in Adults Without Known Liver Disease or With Previously Diagnosed Non-alcoholic Fatty Liver Disease', 'orgStudyIdInfo': {'id': 'SIRIUS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Community cohort', 'description': 'SIRIUS study team will travel to pre-determined sociomes and perform transient elastography and other examinations', 'interventionNames': ['Diagnostic Test: Transient elastography']}, {'label': 'Outpatient cohort', 'description': 'Patients recruited during the elective / preventive examinations at the primary-care clinics or at other outpatient-clinics will have performed Hep-calculator for FIB-4 w/wo transient elastography', 'interventionNames': ['Diagnostic Test: Transient elastography']}], 'interventions': [{'name': 'Transient elastography', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['FIB-4 score'], 'description': 'Both tests belong to the group of non-invasive tests for liver fibrosis (transient elastography belongs to the imaging-based tests and FIB-4 to the blood-based tests)', 'armGroupLabels': ['Community cohort', 'Outpatient cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97401', 'city': 'Banská Bystrica', 'country': 'Slovakia', 'contacts': [{'name': 'Lubomir Skladany, MD, PhD', 'role': 'CONTACT', 'email': 'lubomir.skladany@gmail.com', 'phone': '+421905482997'}, {'name': 'Natalia Bystrianska, MD', 'role': 'CONTACT', 'email': 'naty2121@centrum.sk', 'phone': '+421917944393'}, {'name': 'Daniela Jancekova, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Janka Vnencakova, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'F.D.Roosevelt Teaching Hospital', 'geoPoint': {'lat': 48.73947, 'lon': 19.14932}}, {'zip': '82101', 'city': 'Bratislava', 'country': 'Slovakia', 'contacts': [{'name': 'Tomas Koller, MD, PhD', 'role': 'CONTACT', 'email': 'koller.tomas@gmail.com', 'phone': '+421905118692'}, {'name': 'Juraj Payer, Prof', 'role': 'CONTACT', 'email': 'prof.payer@gmail.com', 'phone': '+421905455079'}], 'facility': 'University Hospital Bratislava', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'zip': '04018', 'city': 'Košice', 'country': 'Slovakia', 'contacts': [{'name': 'Peter Jarčuška, Prof', 'role': 'CONTACT', 'email': 'petjarc@yahoo.com', 'phone': '0905899950'}, {'name': 'Martin Janičko, MD, PhD', 'role': 'CONTACT', 'email': 'martin.janicko@gmail.com', 'phone': '0907178242'}], 'facility': 'Pasteur University Hospital', 'geoPoint': {'lat': 48.71441, 'lon': 21.25802}}], 'centralContacts': [{'name': 'Ľubomír Skladaný, MD, PhD', 'role': 'CONTACT', 'email': 'lubomir.skladany@gmail.com', 'phone': '905482997'}, {'name': 'Svetlana Dr Adamcová Selčanová, MD, PhD', 'role': 'CONTACT', 'email': 'sselcanova@gmail.com'}], 'overallOfficials': [{'name': 'Peter Jarčuška, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Košice'}, {'name': 'Martin Janičko, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University hospital Košice'}, {'name': 'Tomáš Koller, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Bratislava'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Data will be available as of December, 2023 - fo one year', 'ipdSharing': 'YES', 'description': 'The whole dataset except will be shared with prof. Pere Ginés and the LiverScreen investigators', 'accessCriteria': 'Consent of the SIRIUS principal investigator and chairs'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital Bratislava', 'class': 'OTHER'}, {'name': 'University Hospital Kosice', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Ľubomír Skladaný MD, PhD', 'investigatorAffiliation': 'F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica'}}}}