Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-02-28 @ 9:32 AM
Study NCT ID:
NCT07082751
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-24
First Post:
2025-06-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognostic Model for MASLD Related Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 228}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-13', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2030-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-16', 'studyFirstSubmitDate': '2025-06-07', 'studyFirstSubmitQcDate': '2025-07-16', 'lastUpdatePostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'composite endpoint', 'timeFrame': '5 years', 'description': 'cumulative incidence of liver-related events (including decompensation events, hepatocellular carcinoma, liver transplantation, and liver-related mortality) and all-cause mortality.'}], 'secondaryOutcomes': [{'measure': 'Metabolic Diseases', 'timeFrame': '5 years', 'description': 'Number of participants with metabolic disease, including Type 2 Diabetes Mellitus (T2DM), Hypertension, Dyslipidemia'}, {'measure': 'Cardiovascular Diseases (CVD)', 'timeFrame': '5 years', 'description': 'Number of participants with CVD, including Coronary heart disease, Stroke, Heart failure, Atrial fibrillation'}, {'measure': 'Non-Liver Tumors', 'timeFrame': '5 years', 'description': 'Number of participants with non-liver tumors, including colorectal adenoma/adenocarcinoma, gastric cancer, esophageal cancer, pancreatic cancer, gallbladder cancer, lung cancer, prostate cancer, hematological malignancies and so on'}, {'measure': 'non-invasive tests', 'timeFrame': '5 years', 'description': 'changes in non-invasive test, including MRE, MRI-PDFF, LSM, CAP, APRI, FIB-4, NFS, Agile 4'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metabolic Dysfunction Associated Steatotic Liver Disease', 'Compensated Cirrhosis']}, 'descriptionModule': {'briefSummary': 'This study enrolled 228 patients with MASLD-related cirrhosis confirmed by histopathology or clinical diagnosis. Follow-up was conducted every 3-6 months. The primary endpoint was cumulative incidence of liver-related events (including decompensation events, hepatocellular carcinoma, liver transplantation, and liver-related mortality) and all-cause mortality. Secondary endpoints included cumulative incidence of metabolic events and changes in non-invasive fibrosis markers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'MASLD related cirrhosis', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1\\. Men and women aged between 18 and 80 years (inclusive) who understand and sign informed consent forms; 2. Compensated MASLD-related cirrhosis diagnosis(meet one of the following conditions):\n\n1. The liver biopsy during the screening period (liver biopsy within 6 months of screening is acceptable) showing cirrhosis with steatohepatitis according to the Non Alcoholic Fatty Liver Disease Clinical Research Network (NASH-CRN) scoring system, and there is no evidence of competitive aetiology.\n2. The liver biopsy during the screening period (liver biopsy within 6 months of screening is acceptable) showing cirrhosis with steatosis (no steatohepatitis) according to NASH-CRN scoring system, and there is no evidence of competitive aetiology. There are at least 2 coexisting metabolic comorbidities or history of metabolic comorbidities, including overweight/obesity and/or prediabetes/type 2 diabetes mellitus (T2DM).\n3. Historical biopsy showed steatohepatitis, and now diagnosed with cirrhosis through non-invasive tests or clinical criteria (see criterion (6)-1)). There is no evidence of competing aetiology. There is at least 1 coexisting or history of metabolic comorbidity.\n4. Historical biopsy showed steatosis (no steatohepatitis), and now diagnosed with cirrhosis through non-invasive tests or clinical criteria (see criterion (6)-1)). There is no evidence of competing aetiology. There are at least 2 coexisting metabolic comorbidities or history of metabolic comorbidities, including overweight/obesity and/or prediabetes/type 2 diabetes mellitus (T2DM).\n5. 'Cryptogenic cirrhosis' (with no evidence of hepatic steatosis on both histopathology and imaging). There is no evidence of competing aetiology. There are at least 2 coexisting metabolic comorbidities or history of metabolic comorbidities, including overweight/obesity and/or prediabetes/type 2 diabetes mellitus (T2DM).\n6. MASLD-related cirrhosis is defined based on the following criterias:\n\n a. Cirrhosis is defined based on one of the following non-invasive tests(NITS): i: MRE ≥ 5kPa or VCTE-LSM ≥ 20kPa; ii:VCTE ≥15 kPa and \\<20 kPa and 1 of the following: MRE≥4.2kPa or Agile4≥0.565 or Platelets≤150,000/µL; iii: VCTE \\<15 kPa and 2 of the following: MRE≥4.2kPa or Agile4≥0.565 or Platelets≤150,000/µL; b. Current or previous imaging examinations have diagnosed fatty liver or controlled attenuation parameter (CAP)≥288dB/m or magnetic resonance imaging proton density fat fraction (MRI-PDFF)≥5%.\n\n c. There is no evidence of competing aetiology; d. There are at least 2 coexisting metabolic comorbidities or history of metabolic comorbidities, including overweight/obesity and/or prediabetes/type 2 diabetes mellitus (T2DM).\n\n Exclusion Criteria:\n * 1\\. Other chronic liver diseases (including but not limited to viral hepatitis, alcoholic liver disease, drug-induced liver injury, autoimmune liver disease, Wilson's disease, hemochromatosis, etc.) 2. There has been a continuous history of heavy drinking for 3 months or more current or rencent 5 years (heavy drinking is defined as \\>20 g/day in women and \\>30 g/day in men); Or researchers can not reliably quantify alcohol consumption.\n\n 3\\. Hepatic decompensation events (including ascites, esophageal and gastric variceal bleeding, hepatic encephalopathy, hepatorenal syndrome, spontaneous bacterial peritonitis, etc.) or hepatocellular carcinomaor.\n\n 4\\. Previous (\\<5 years before screening) treatment for obesity with surgery; 5. Have obesity induced by other endocrinologic disorders (i.e. Cushing Syndrome) genetic diseases; 6. Secondary factors that can cause liver steatosis, such as malnutrition, medication, genetic metabolic diseases, etc.\n\n 7\\. Positive for human immunodeficiency virus (HIV) infection; 8. History of drug use or abuse of drugs within the 12 months prior to screening.\n\n 9\\. Pregnant or lactating women; 10. Researchers believe that patients who are not suitable to participate in this study."}, 'identificationModule': {'nctId': 'NCT07082751', 'briefTitle': 'Prognostic Model for MASLD Related Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Friendship Hospital'}, 'officialTitle': 'Prognostic Model for Metabolic Dysfunction-associated Steatotic Liver Disease Related Cirrhosis', 'orgStudyIdInfo': {'id': '2025-P2-166-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MASLD-related compensated cirrhosis', 'description': 'MASLD-related compensated cirrhosis confirmed by histopathology or clinical diagnosis', 'interventionNames': ['Behavioral: Lifestyle Guidance']}], 'interventions': [{'name': 'Lifestyle Guidance', 'type': 'BEHAVIORAL', 'description': 'Lifestyle Guidance', 'armGroupLabels': ['MASLD-related compensated cirrhosis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Jing jie Zhao, M.D.', 'role': 'CONTACT', 'email': 'zhaojj@ccmu.edu.cn', 'phone': '01063138328'}], 'facility': 'Beijing Friendship Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Linheng Wang', 'role': 'CONTACT', 'email': 'wanglinheng@sina.com', 'phone': '+86 13370129665'}], 'facility': 'Beijing University of Chinese Medicine Dongfang Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'China', 'country': 'China', 'contacts': [{'name': 'Song Yang', 'role': 'CONTACT', 'email': 'sduyangsong@163.com', 'phone': '+86 15011210692'}], 'facility': 'Beijing Ditan Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'China', 'country': 'China', 'contacts': [{'name': 'Baohong Xu', 'role': 'CONTACT', 'email': 'bhxu22@126.com', 'phone': '+86 15810395596'}], 'facility': 'Beijing Luhe Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'China', 'country': 'China', 'contacts': [{'name': 'Yuan Huang', 'role': 'CONTACT', 'phone': '+86 17701306499'}], 'facility': 'Beijing Tsinghua Changgung Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'China', 'country': 'China', 'contacts': [{'name': 'Jing Zhang', 'role': 'CONTACT', 'email': 'zjyouan@ccmu.edu.cn', 'phone': '+86 13391859683'}], 'facility': 'Beijing Youan Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'China', 'country': 'China', 'contacts': [{'name': 'Huiying Rao', 'role': 'CONTACT', 'email': 'strangehead@163.com', 'phone': '+86 13621390945'}], 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Tianjin', 'state': 'China', 'country': 'China', 'contacts': [{'name': 'Liang Xu', 'role': 'CONTACT', 'email': 'xuyangliang2004@sina.com', 'phone': '+86 13602162403'}], 'facility': "Tianjin Second People's Hospital", 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Beijing', 'state': 'C', 'country': 'China', 'contacts': [{'name': 'Li Li', 'role': 'CONTACT', 'phone': '+86 13810686326'}], 'facility': 'Beijing Hospital of Traditional Chinese Medicine', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jing jie Zhao, M.D.', 'role': 'CONTACT', 'email': 'zhaojj@ccmu.edu.cn', 'phone': '01063138328'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'After the project finished', 'ipdSharing': 'YES', 'description': 'Patient Demographics, Anthropometrics, Serological, and Imaging Data, and Liver Biopsy Scores', 'accessCriteria': 'ask the principle investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Friendship Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice president of hospital', 'investigatorFullName': 'Hong You', 'investigatorAffiliation': 'Beijing Friendship Hospital'}}}}