Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:57 AM
Study NCT ID:
NCT07433205
Status:
COMPLETED
Last Update Posted:
2026-02-25
First Post:
2026-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Risk Factors and Prognosis of MASLD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 922}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-20', 'studyFirstSubmitDate': '2026-02-20', 'studyFirstSubmitQcDate': '2026-02-20', 'lastUpdatePostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fibrosis progression (noninvasive)', 'timeFrame': 'Baseline to 2 years.', 'description': 'Change in liver fibrosis stage/risk assessed by transient elastography (liver stiffness measurement, LSM) and/or validated fibrosis scores (e.g., FIB-4, NAFLD Fibrosis Score).'}, {'measure': 'Composite liver-related clinical events', 'timeFrame': 'Baseline to 2 years.', 'description': 'Incidence of liver-related events (composite), including hepatic decompensation (ascites, variceal bleeding, hepatic encephalopathy), new diagnosis of cirrhosis, hepatocellular carcinoma, liver transplantation, or liver-related death.'}], 'secondaryOutcomes': [{'measure': 'Steatosis change', 'timeFrame': 'Baseline to 2 years.', 'description': 'Change in hepatic steatosis assessed by CAP (controlled attenuation parameter) and/or imaging (ultrasound/CT/MRI-PDFF if available).'}, {'measure': 'Liver enzymes improvement/worsening', 'timeFrame': 'Baseline to 2 years.', 'description': 'Change in ALT and AST levels.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)']}, 'descriptionModule': {'briefSummary': 'This longitudinal cohort study will enroll individuals with MASLD (and/or those at risk) and follow them over time to identify clinical and metabolic risk factors for disease progression and to evaluate predictors of long-term outcomes, including fibrosis progression and liver-related events, major cardiovascular events, and all-cause mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults aged 20-90 years will be enrolled into a prospective observational cohort, including participants with MASLD and a comparison cohort without MASLD at baseline, recruited from the same source population. Participants will undergo standardized clinical assessment, laboratory testing, and noninvasive liver evaluation at baseline and during follow-up for up to 2 years to assess metabolic risk factors, MASLD progression, and clinical outcomes.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nAge 20 to 90 years at enrollment. Able and willing to provide written informed consent. Willing and able to comply with study assessments and follow-up for up to 2 years.\n\nAvailability of baseline clinical evaluation and laboratory tests required by the protocol.\n\nFor the MASLD cohort: Evidence of hepatic steatosis at baseline (e.g., imaging and/or noninvasive assessment) in the presence of metabolic dysfunction, consistent with contemporary MASLD criteria, and without alternative causes of steatosis per protocol.\n\nFor the Control cohort: No evidence of MASLD/ hepatic steatosis at baseline (based on available imaging and/or noninvasive assessment), recruited from the same source population.\n\nExclusion Criteria:\n\nSignificant alcohol consumption exceeding protocol-defined thresholds. Known chronic liver diseases other than MASLD (including but not limited to chronic hepatitis B or C, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, Wilson's disease, hemochromatosis, or alpha-1 antitrypsin deficiency).\n\nHistory of hepatocellular carcinoma, liver transplantation, or other active malignancy (except adequately treated non-melanoma skin cancer or carcinoma in situ) that may interfere with follow-up.\n\nDecompensated liver disease at baseline (e.g., ascites, variceal bleeding, hepatic encephalopathy) if not intended to be included per protocol.\n\nUse of medications known to cause hepatic steatosis or steatohepatitis (e.g., amiodarone, methotrexate, systemic corticosteroids, tamoxifen) within a protocol-defined period, if judged to be the primary cause of steatosis.\n\nPregnancy or breastfeeding at enrollment (if applicable to your protocol assessments).\n\nAny serious medical condition or psychiatric disorder that, in the investigator's opinion, would make participation unsafe or interfere with study assessments or follow-up."}, 'identificationModule': {'nctId': 'NCT07433205', 'briefTitle': 'Study on Risk Factors and Prognosis of MASLD', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Chongqing Medical University'}, 'officialTitle': 'Risk Factors and Prognosis of Metabolic Dysfunction-Associated Steatotic Liver Disease', 'orgStudyIdInfo': {'id': '20260220'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control', 'description': 'Participants without MASLD at baseline, serving as a comparison cohort. Individuals will be recruited from the same source population as the MASLD cohort and will undergo the same standardized baseline assessment and follow-up schedule, including clinical evaluation, laboratory testing, and noninvasive liver assessment as applicable. Participants will be followed for incident MASLD and longitudinal changes in metabolic risk factors and clinical outcomes during the study period.'}, {'label': 'MASLD', 'description': 'Participants with MASLD at baseline, defined according to contemporary clinical criteria based on evidence of hepatic steatosis in the presence of metabolic dysfunction and in the absence of alternative causes of steatosis as specified in the protocol. Participants will undergo standardized baseline assessment and longitudinal follow-up, including clinical evaluation, laboratory testing, and noninvasive liver assessment (e.g., transient elastography and/or other validated measures as available). Follow-up will evaluate MASLD progression (including worsening steatosis and/or fibrosis) and the occurrence of clinical outcomes, such as liver-related events and major cardiovascular events, as well as all-cause mortality.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': "Sichuan University affiliated Chengdu Second People's Hospital", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'overallOfficials': [{'name': 'Xuesong Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'First Affiliated Hospital of Chongqing Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Chongqing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Xuesong Wen', 'investigatorAffiliation': 'First Affiliated Hospital of Chongqing Medical University'}}}}