Mount Sinai Regional Drug Induced Liver Injury Network Site

西奈山地区药物性肝损伤网络网站

基本信息

批准号：
9986082
负责人：
Jawad Ahmad
金额：
$ 6.59万
依托单位：
ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-08-15 至 2023-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9986082
关键词：
Adult African American Area Asians Ayurvedic Medicine Biological Markers Blood specimen Body Weight decreased Caring Caucasians Child Chinese People Chronic Disease Cities Clinical Computerized Medical Record Coupled Databases Diagnosis Early Diagnosis Enrollment Ethnic Origin Etiology Evaluation Formulation Funding General Practitioners Genetic Genetic Markers Geography Goals Health Personnel Health system Hepatology Herbal supplement Hispanics Hospitals Human Resources Injury Institutes Institution Internist Lead Literature Liver Liver diseases Location Malignant Neoplasms Melatonin Minority Modeling National Institute of Diabetes and Digestive and Kidney Diseases New York New York City Outpatients Pathogenesis Pathologic Patient Recruitments Patients Pediatric Hospitals Pharmaceutical Preparations Positioning Attribute Predisposing Factor Prevention Prospective cohort Protocols documentation Provider Publishing Research Personnel Risk Serum Site Source South American South Asian System Time acute drug induced liver toxicity authority chemotherapy clinical research site cohort data mining drug testing ethnic difference ethnic diversity ethnic minority population expectation follow-up genetic risk factor interest liver injury member metropolitan outreach program prevent prospective racial and ethnic racial difference recruit repository response tool urban area urologic web site

项目摘要

The Drug Induced Liver Injury Network (DILIN), sponsored by NIDDK was established in 2003 to identify cases of DILI across a diverse demographic and geographic spectrum. Mount Sinai has been an integral part of the DILIN since 2013 and helped the network increase recruitment such that patient accrual now exceeds expectations. The current 6 clinical sites have performed very well, with Mount Sinai among the leading enrolling sites, particularly for acute DILI cases. The integration of several new hospitals to the Mount Sinai Health System and formation of a Liver Institute to organize hepatology care across the health system will likely result in an increase in enrollment from the Mount Sinai DILIN site with added ethnic diversity. As a whole, the DILIN is well positioned to embark on important goals: continuing to recruit patients early in the course of illness to identify DILI biomarkers; increase the racial/ethnic diversity of patients in the prospective cohort by focused recruitment in urban areas; enrollment of herbal and dietary supplement (HDS) cases along with analysis of HDS products collected in the repository; setting up systems for early detection of drugs or HDS associated with DILI to assist regulatory authorities; and continuing to provide accurate clinical information about DILI through published literature and support for the Livertox website. The Specific Aims for the Mount Sinai site are as follows: 1) To enroll adults and children with DILI in the current DILIN prospective and retrospective databases; 2) To specifically enroll patients early in the course of suspected DILI; 3) To enrich the current DILIN prospective and retrospective databases with patients of non-Caucasian ethnicity; 4) To evaluate serum and genetic biomarkers for chemotherapy-induced liver injury and determine if melatonin pretreatment prevents chemotherapy-induced liver injury; and 5) To rapidly identify newly approved prescription medications and new HDS formulations that cause unexpected concentrations of DILI cases.

由 NIDDK 赞助的药物性肝损伤网络 (DILIN) 于 2003 年成立，旨在识别病例 DILI 涵盖不同的人口和地理范围。西奈山一直是这个国家不可分割的一部分 DILIN 自 2013 年起帮助该网络增加招募，目前患者数量已超过期望。目前的 6 个临床中心表现非常好，其中西奈山是领先的招募地点，特别是急性 DILI 病例。几家新医院整合到西奈山卫生系统和成立肝脏研究所来组织整个卫生系统的肝病护理将可能会导致西奈山 DILIN 站点的入学人数增加，并增加种族多样性。作为一个总体而言，DILIN 处于有利地位，可以实现重要目标：继续在早期招募患者病程以识别 DILI 生物标志物；前瞻性地增加患者的种族/民族多样性在城市地区集中招聘；草药和膳食补充剂 (HDS) 病例登记对存储库中收集的 HDS 产品进行分析；建立早期发现毒品的系统或 HDS 与 DILI 合作，协助监管机构；并持续提供准确的临床通过已发表的文献和对 Livertox 网站的支持了解有关 DILI 的信息。具体目标西奈山站点如下： 1) 将患有 DILI 的成人和儿童纳入当前的 DILIN 前景和回顾性数据库； 2) 在疑似 DILI 病程早期专门招募患者； 3) 至丰富当前 DILIN 前瞻性和回顾性数据库中的非白人患者； 4）评估化疗引起的肝损伤的血清和遗传生物标志物，并确定褪黑激素是否预处理可预防化疗引起的肝损伤； 5) 快速识别新批准的处方药和新的 HDS 制剂会导致 DILI 病例浓度意外增加。