Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-25 @ 7:38 PM
Study NCT ID:
NCT05181332
Status:
UNKNOWN
Last Update Posted:
2022-01-20
First Post:
2021-12-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Predictive Models of Hepatic Decompensation and Survival Outcomes in Pediatric Patients With Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D001656', 'term': 'Biliary Atresia'}, {'id': 'D015529', 'term': 'Choledochal Cyst'}, {'id': 'D015209', 'term': 'Cholangitis, Sclerosing'}, {'id': 'D019693', 'term': 'Hepatitis, Autoimmune'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004065', 'term': 'Digestive System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002761', 'term': 'Cholangitis'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-05', 'studyFirstSubmitDate': '2021-12-17', 'studyFirstSubmitQcDate': '2021-12-17', 'lastUpdatePostDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hepatic decompensation', 'timeFrame': 'At least 5-year follow up', 'description': 'The primary outcome was the first event of hepatic decompensation, defined by the occurrence of any of the following: ascites (identified or confirmed by abdominal ultrasound), upper gastrointestinal bleeding secondary to portal hypertension (confirmed by endoscopy in the presence of gastroesophageal varices or portal hypertensive gastropathy), or hepatic encephalopathy (established by clinical parameters, neuropsychological tests, or electroencephalogram)'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'At least 5-year follow up', 'description': 'The endpoint was defined as the occurrence of death or the last follow-up. Patients were followed from the day of liver biopsy until the occurrence of death, liver transplant, or last visit. The outcome was evaluated by an experienced hepatologist in each center every 3-6 months. At each visit, a medical history, physical examination, and standard laboratory tests were performed.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cirrhosis', 'Biliary Atresia', 'Choledochal Cyst', 'Primary Sclerosing Cholangitis', 'HBV', 'HCV', 'Autoimmune Hepatitis']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to developed and validated models to predict hepatic decompensation and survivals in pediatric patients with cirrhosis and compared these models with currently available models.', 'detailedDescription': 'Noninvasive liver fibrosis tests such as the NAFLD fibrosis score (NFS), Hepascore, and transient elastography were specifically developed to predict fibrosis and can help predict patients with NAFLD at the highest risk of developing liver-related complications. These tests have been widely applied in adult cirrhosis. The accuracy of these models, however, may be influenced by patient factors including age, body mass index, and diabetes, potentially limiting their prognostic accuracy and clinical practicability in children. Therefore, it is currently unknown how to best predict hepatic decompensation and survival outcomes among pediatric patients with cirrhosis. To fill this knowledge gap, the investigators performed a retrospective-prospective cohort study with the aim of developing and validating a clinical model to predict liver-related complications and survival outcomes in pediatric patients with biopsy-proven with cirrhosis. Secondly, the investigators aimed to compare the predictive accuracy with currently available noninvasive model.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '0 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric patients with cirrhosis who were diagnosed histologically with definite pathologic specimens.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age up to 18 years old\n* No previous episodes of clinical decompensation\n* With written informed consent\n\nExclusion Criteria:\n\n* Clinical data missing\n* Without written informed consent'}, 'identificationModule': {'nctId': 'NCT05181332', 'briefTitle': 'Predictive Models of Hepatic Decompensation and Survival Outcomes in Pediatric Patients With Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'West China Hospital'}, 'officialTitle': 'Predictive Models of Hepatic Decompensation and Survival Outcomes in Pediatric Patients With Cirrhosis', 'orgStudyIdInfo': {'id': 'HX-2021523'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Retrospective cohort', 'description': 'The internal cohort was retrospectively enrolled in West China Hospital, Sichuan University from June 2010 and December 2020. It is a training and internal validation cohort.', 'interventionNames': ['Other: Prediction model']}, {'label': 'Prospective cohort', 'description': 'The same inclusion/exclusion criteria were applied for the same center prospectively. It is a external validation cohort.', 'interventionNames': ['Other: Prediction model']}], 'interventions': [{'name': 'Prediction model', 'type': 'OTHER', 'description': 'Clinical models were developed and validated to predict liver-related complications and survival outcomes in pediatric patients with biopsy-proven with cirrhosis.', 'armGroupLabels': ['Prospective cohort', 'Retrospective cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6100000', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuhan Yang, MD', 'role': 'CONTACT', 'email': 'yyh_1023@163.com', 'phone': '8613258389785'}], 'facility': 'West China Hospital, Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Yuhan Yang, MD', 'role': 'CONTACT', 'email': 'yyh_1023@163.com', 'phone': '8613258389785'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West China Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Yuhan Yang', 'investigatorAffiliation': 'West China Hospital'}}}}