Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT06101758
Status:
UNKNOWN
Last Update Posted:
2023-10-26
First Post:
2023-09-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasound Assessment of Sarcopenia in Patients With Chronic Liver Disease: the SARCOLIVER Study
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'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], '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'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 125}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-20', 'studyFirstSubmitDate': '2023-09-04', 'studyFirstSubmitQcDate': '2023-10-20', 'lastUpdatePostDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To calculate the prevalence of the condition of sarcopenia in patients with liver cirrhosis, non-alcoholic fatty liver disease and hepatocellular carcinoma', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'Association among sarcopenia and survival or acute decompensation events in patients with liver cirrhosis', 'timeFrame': '24 months'}, {'measure': 'To calculate the prevalence of obesity with sarcopenia in patients with non-alcoholic fatty liver disease', 'timeFrame': '24 months'}, {'measure': 'To evaluate the association among sarcopenia and therapeutic response in patients with hepatocellular carcinoma', 'timeFrame': '24 months'}, {'measure': "To calculate cohen's Kappa to evaluate the concordance among muscular ultrasound and dual-energy X-ray absorption, computed tomography scan and magnetic resonance imaging in the detection of sarcopenia", 'timeFrame': '24 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Cirrhosis', 'Non-Alcoholic Fatty Liver Disease', 'Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'Sarcopenia is a complex multifactorial syndrome which could be present in older age (primary sarcopenia) or earlier in chronic disease (secondary sarcopenia). Even if in patients with chronic liver disease an association among sarcopenia and poor clinical outcomes is well known, the data available about the prevalence of sarcopenia in patients with liver cirrhosis, non-alcoholic fatty liver disease and hepatocellular carcinoma are very variable according to the populations in object and, furthermore, few data are available regarding the use of muscular ultrasound to detect this condition. The aim of this study is to define the prevalence of sarcopenia in patients with liver cirrhosis, non-alcoholic fatty liver disease and hepatocellular carcinoma in follow-up at our center and the clinical outcomes associated with this condition, and to determine the reliability of muscular ultrasound to diagnose the condition of sarcopenia through a comparison with other validated techniques such as computed tomography, magnetic resonance imaging and dual-energy X-ray absorptiometry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to express informed consent\n* Diagnosis of liver cirrhosis or non-alcoholic fatty liver disease or hepatocellular carcinoma based on clinical characteristics, biochemical serum tests and liver imaging examination or liver histologic examination if available\n\nExclusion Criteria:\n\n* inability to express informed consent\n* pregnancy\n* presence of a concomitant oncologic disease different from hepatocellular carcinoma\n* presence of a concomitant gastrointestinal disease able to influence the absorption and digestion of nutrients (e.g. inflammatory bowel disease, celiac disease, short-bowel syndrome, congenital defects of metabolism)\n* presence of a concomitant gastrointestinal or neurologic disease able to influence the ability of feeding (e.g. dysphagia, parkinson disease, neuromuscular diseases, diseases of the autonomic nervous system, cognitive impairment or dementia)\n* chronic kidney disease from stage 3 B (IIIB) according to Kidney Disease: Improving Global Outcomes (KDIGO) classification (eGFR \\<45ml/min/1.73m2)\n* chronic heart failure from stage Ney York Heart Association (NYHA) II\n* concomitant infection from Mycobacterium Tuberculosis or human immunodeficiency virus or chronic parasitic infections'}, 'identificationModule': {'nctId': 'NCT06101758', 'acronym': 'SARCOLIVER', 'briefTitle': 'Ultrasound Assessment of Sarcopenia in Patients With Chronic Liver Disease: the SARCOLIVER Study', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Prospective Study of Ultrasound Assessment of Sarcopenia and Correlated Clinical Outcomes in Patients With Chronic Liver Disease: the SARCOLIVER Study', 'orgStudyIdInfo': {'id': '5855'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Muscular ultrasound assessment', 'description': 'Adult patients aged 18-69 years with a diagnosis of either liver cirrhosis, non-alcoholic fatty liver disease or hepatocellular carcinoma', 'interventionNames': ['Diagnostic Test: Handgrip strength test', 'Diagnostic Test: total body Dual Energy X-Ray Absorptiometry (DXA)', 'Diagnostic Test: Muscle ultrasound']}], 'interventions': [{'name': 'Handgrip strength test', 'type': 'DIAGNOSTIC_TEST', 'description': 'A handgrip strength test using a hydraulic hand dynamometer will be performed', 'armGroupLabels': ['Muscular ultrasound assessment']}, {'name': 'total body Dual Energy X-Ray Absorptiometry (DXA)', 'type': 'DIAGNOSTIC_TEST', 'description': 'A total body Dual Energy X-Ray Absorptiometry (DXA) to estimate muscle mass will be performed', 'armGroupLabels': ['Muscular ultrasound assessment']}, {'name': 'Muscle ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'A muscular ultrasound of abdominal muscles, forearm muscles, quadriceps and gastrocnemius will be performed', 'armGroupLabels': ['Muscular ultrasound assessment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Roma', 'state': 'RM', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Maria Assunta Zocco', 'role': 'CONTACT'}], 'facility': 'CEMAD', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'centralContacts': [{'name': 'Maria Assunta Zocco', 'role': 'CONTACT', 'email': 'Mariaassunta.zocco@policlinicogemelli.it', 'phone': '063015 1'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof', 'investigatorFullName': 'Zocco Maria Assunta', 'investigatorAffiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}}}}