A PROSPECTIVE DATABASE OF INFANTS WITH CHOLESTASIS

胆汁淤积婴儿的前瞻性数据库

• 批准号: 7605093
• 负责人: RONALD J. SOKOL
• 金额: $ 0.33万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2008-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7605093
• 关键词: Age-Years; Ancillary Study; Bile fluid; Biliary; Biliary Atresia; Biological; Biopsy; Blood; Blood specimen; Caring; Child; Cholestasis; Clinical; Computer Retrieval of Information on Scientific Projects Database; Condition; Data; Databases; Diagnosis; Diagnostic; Enrollment; Female; Funding; Future; Gene Proteins; Genomics; Grant; Infant; Institution; Lead; Liver; Liver diseases; Medical; Medical History; Natural History; Neonatal; Operative Surgical Procedures; Parents; Pathogenesis; Pattern; Plasma; Population Study; Proteomics; Purpose; Recovery; Research; Research Personnel; Resources; Sampling; Source; Specimen; Standards of Weights and Measures; Techniques; Time; Tissue Sample; Tissues; Transplantation; United States National Institutes of Health; Urine; Viral; clinical research site; day; follow-up; liver transplantation; male; neonatal hepatitis; prospective; protein expression; repository

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The primary objectives of this research are to establish (1) a database containing clinical information and (2) a repository of blood and tissue samples from children with neonatal liver diseases such as biliary atresia and neonatal hepatitis to facilitate research in these important liver problems in children. This database and the specimens will be available for ancillary studies that will investigate the pathogenesis and natural history of biliary atresia and neonatal hepatitis or to evaluate patterns of cellular gene and protein expression in tissue specimens and plasma by viral, genomic and proteomic techniques. The study population will consist of infants, both male and female, with cholestasis who are less than or equal to 180 days old at the time of diagnosis at a Biliary Atresia Research Consortium (BARC) clinical site. In order to study the natural history, subjects will be followed until 10 years of age, liver transplantation or, for children without biliary atresia, until complete recovery off of all therapy. This study will: 1. collect detailed clinical and demographic information about each subject at enrollment and during follow up, 2. obtain and store blood and urine samples from the subject at diagnosis and during follow up, 3. obtain and store liver and biliary tissue and bile that are removed during diagnosis (i.e., biopsy) or at time of surgery or transplant and that are not needed for diagnostic purposes 4. collect demographic and medical history of parents at enrollment, and 5. obtain and store blood from the biological parents at enrollment. Samples of blood, urine, bile and tissue will be stored in repositories for future research. The data and biological specimens will be used for detailed study into the mechanisms and causes of liver problems in young children in order to try to better diagnose and manage these conditions. The subject will receive standard-of-care treatment and will not be restricted in type of treatment or from changes in treatment, such as newer treatments as they are developed. The subjects may not directly benefit from participation in this research, but in the future other children with similar problems may benefit from new information that may lead to better medical care.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这项研究的主要目标是建立(1)包含临床信息的数据库和(2)来自患有胆道闭锁和新生儿肝炎等新生儿肝脏疾病的儿童的血液和组织样本的储存库，以促进对这些重要儿童肝脏问题的研究。该数据库和标本将用于辅助研究，这些研究将调查胆道闭锁和新生儿肝炎的发病机制和自然历史，或利用病毒、基因组和蛋白质组技术评估组织标本和血浆中细胞基因和蛋白质的表达模式。研究人群将包括在胆道闭锁研究联盟(BARC)临床站点确诊时小于或等于180天的胆汁淤积婴儿，男性和女性。为了研究自然历史，受试者将被跟踪到10岁，进行肝移植，或者对于没有胆道闭锁的儿童，直到完全从所有治疗中恢复。 这项研究将： 1.在登记时和后续行动中收集关于每个受试者的详细临床和人口学信息， 2.在诊断时和随访期间获取并储存受试者的血液和尿液样本， 3.获取和储存在诊断期间(即活组织检查)或在手术或移植时被切除的、不需要用于诊断目的的肝脏、胆管组织和胆汁。 4.在入学时收集父母的人口统计和病史，以及 5.在入学时从亲生父母那里获取和储存血液。 血液、尿液、胆汁和组织的样本将储存在储存库中，以供未来研究。这些数据和生物标本将用于详细研究幼儿肝脏问题的机制和原因，以尝试更好地诊断和管理这些情况。受试者将接受标准治疗，不会受到治疗类型的限制，也不会因治疗的变化而受到限制，例如随着新疗法的发展。受试者可能不会从参与这项研究中直接受益，但未来其他有类似问题的儿童可能会从新的信息中受益，这些信息可能会导致更好的医疗保健。