Biliary Atresia Consortium: Data Coordinating Center

胆道闭锁联盟：数据协调中心

• 批准号: 7288713
• 负责人: JOHN C MAGEE
• 金额: $ 99.12万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-18 至 2009-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7288713
• 关键词: Biliary Atresia; Biometry; Case Report Form; Child; Childhood; Clinical; Clinical Data; Clinical Research; Clinical Trials Data Monitoring Committees; Conduct Clinical Trials; Core Facility; Data; Data Analyses; Data Coordinating Center; Data Quality; Databases; Development; Evaluation; Facility Construction Funding Category; Goals; Hepatology; Hyperbilirubinemia; Icterus; Liver diseases; Living Costs; Mission; Monitor; Multicenter Trials; Natural History; Newborn Infant; Online Systems; Patients; Pediatric Surgical Procedures; Preparation; Procedures; Progress Reports; Protocols documentation; Publications; Quality of life; Randomized; Reporting; Research; Research Personnel; Role; Serum; Site; Specimen; Steroid therapy; Therapeutic Human Experimentation; Therapy Clinical Trials; Tissue Sample; Transplantation; Unexpected Adverse Event; Work; cohort; demographics; design; experience; neonatal hepatitis; prospective; repository

DESCRIPTION (provided by applicant): Biliary atresia and idiopathic neonatal hepatitis are the most common causes of jaundice and hyperbilirubinemia, which extends beyond the newborn period. The long-term goal of the Biliary Atresia Research Clinical Research Consortium (BACRC) is to establish a database of clinical information and serum and tissue samples from children with biliary atresia (BA) and idiopathic neonatal hepatitis (INH) to facilitate and perform clinical, epidemiological and therapeutic research in these two important pediatric liver diseases. This application to be the DCC brings together experienced investigators from biostatistics, pediatric surgery, pediatric hepatology and transplantation. The DCC will: 1. Establish longitudinal cohort database for patients with BA and INH 2. Provide expertise in the design, conduct, and analysis of multicenter trials 3. Coordinate the implementation of the study protocols approved by the steering committee, including centralized database management with either centralized or remote data entry 4. Monitor sites with respect to data quality 5. Develop the plan for the data analysis, perform the analysis and collaborate on the preparation to the publications that will result from these studies6. Establish and maintain a Specimen Core Facility to serve as a central repository for the BACRC. 7. In our application we propose the construction of a longitudinal cohort database and detail how such information would be used to analyze the natural history of patients with biliary atresia who undergo a Kasai procedure. We also propose a multicenter prospective randomized clinical trail of steroid therapy after the Kasai procedure to highlight the role of the DCC in this mission. It is recognized the steering committee will develop and approve all protocols to be implemented.

描述（由申请人提供）： 胆道闭锁和特发性新生儿肝炎是黄疸和高胆红素血症的最常见原因，这种情况会持续到新生儿期之后。胆道闭锁研究临床研究联盟 (BACRC) 的长期目标是建立胆道闭锁 (BA) 和特发性新生儿肝炎 (INH) 儿童的临床信息以及血清和组织样本数据库，以促进和开展临床、这两种重要的小儿肝脏疾病的流行病学和治疗研究。该应用程序将成为 DCC，汇集了来自生物统计学、小儿外科、小儿肝病学和移植领域经验丰富的研究人员。 DCC 将： 1. 建立 BA 和 INH 患者的纵向队列数据库 2. 提供多中心试验的设计、实施和分析方面的专业知识 3. 协调指导委员会批准的研究方案的实施，包括集中数据库管理通过集中或远程数据输入 4. 监控站点的数据质量 5. 制定数据分析计划，执行分析并协作准备这些研究结果的出版物6。 建立并维护样本核心设施，作为 BACRC 的中央存储库。 7. 在我们的申请中，我们建议构建一个纵向队列数据库，并详细说明如何使用这些信息来分析接受 Kasai 手术的胆道闭锁患者的自然史。我们还提出了 Kasai 手术后类固醇治疗的多中心前瞻性随机临床试验，以强调 DCC 在这一任务中的作用。人们认识到指导委员会将制定并批准所有要实施的协议。