Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2025-12-24 @ 4:59 PM
Study NCT ID:
NCT03842150
Status:
RECRUITING
Last Update Posted:
2022-12-28
First Post:
2019-02-13
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Development and Validation of a Screening Score for the Biliary Atresia in Infantile Cholestasis: A Prospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001656', 'term': 'Biliary Atresia'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-25', 'studyFirstSubmitDate': '2019-02-13', 'studyFirstSubmitQcDate': '2019-02-13', 'lastUpdatePostDateStruct': {'date': '2022-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development and Validation a Screening Score for the biliary atresia in infantile cholestasis', 'timeFrame': '1 weeks', 'description': 'Developed a scoring system according to clinical, laboratory, imaging features of BA and test it in the clinical work. The score system might including clay stool, γ-glutamyl transpeptadase, the results of ultrasound and subscales selected for logistic regression. The total score would sum all the subscales up.The investigators grade the patients with the cholestasis screen score to identify patients with biliary atresia. Patients with score ≤ 15 points considered to be the low-risk group, and patients with risk score \\> 15 points considered the high-risk group, and the score model has no maximum or minimum value.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Biliary Atresia', 'Neonatal Cholestasis', 'Infantile Hepatitis Syndrome']}, 'descriptionModule': {'briefSummary': 'Better survival and prognosis of biliary atresia (BA) depend on early diagnosis and timely Kasai portoenterostomy. Identifying BA from other causes of infantile cholestasis at early stage of the disease still remains a major challenge. In this study, the investigators aim to develop and validate a scoring system to screen BA in infants with cholestasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Months', 'minimumAge': '1 Day', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'infants with cholestasis inclduing biliary atresia', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nClinical diagnosis of neonatal cholestasis Age at first visit less than 90 days after birth\n\nExclusion Criteria:\n\nSevere congenital malformation Subjects with missing data'}, 'identificationModule': {'nctId': 'NCT03842150', 'briefTitle': 'Development and Validation of a Screening Score for the Biliary Atresia in Infantile Cholestasis: A Prospective Study', 'organization': {'class': 'OTHER', 'fullName': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Development and Validation of a Screening Score for the Biliary Atresia in Infantile Cholestasis: A Prospective Study', 'orgStudyIdInfo': {'id': 'XH-19-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'derivation cohort', 'interventionNames': ['Diagnostic Test: biliary atresia screen score']}, {'label': 'validation cohort', 'interventionNames': ['Diagnostic Test: biliary atresia screen score']}], 'interventions': [{'name': 'biliary atresia screen score', 'type': 'DIAGNOSTIC_TEST', 'description': 'The investigators aim to develop a scoring system according to clinical, laboratory, imaging features of biliary atresia in the derivation dataset and tested in the validation datasets.', 'armGroupLabels': ['derivation cohort', 'validation cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200092', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yongjun Zhang, doctor', 'role': 'CONTACT'}], 'facility': 'Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Yongjun Zhang, doctor', 'role': 'CONTACT', 'email': 'zhangyongjun@sjtu.edu.cn', 'phone': '+8602125078310'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The investigators plan to share all the individual participant data information available to our cooperative hospitals through emails'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}