Mount Sinai Regional Drug Induced Liver Injury Network Site

西奈山地区药物性肝损伤网络网站

• 批准号: 9769719
• 负责人: Jawad Ahmad
• 金额: $ 38.45万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 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/9769719
• 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

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赞助的药物肝损伤网络(DILIN)成立于2003年，目的是识别病例 在不同的人口统计和地理范围内，帝力是最重要的。西奈山一直是 DILIN自2013年以来，并帮助该网络增加招聘，使患者收益现在超过 期望值。目前的6个临床站点表现非常好，西奈山是领先的 登记地点，特别是急性帝力病例的登记地点。将几家新医院整合到西奈山 卫生系统和成立肝脏研究所以组织整个卫生系统的肝病护理将 可能导致来自西奈山迪林山遗址的入学人数增加，增加了种族多样性。作为一名 总体而言，DILIN处于有利地位，可以着手实现重要目标：继续在早期招募患者 病程以确定DILI生物标志物；增加未来患者的种族/民族多样性 通过在城市地区集中招募进行队列；草药和膳食补充剂(HDS)病例的登记 对储存库中收集的HDS产品进行分析；建立早期检测药物或 与DILI相关的HDS协助监管当局；并继续提供准确的临床 通过出版的文献和对利物浦毒素网站的支持，了解有关帝力的信息。具体目标是 西奈山网站如下：1)招募患有DILI的成人和儿童参加目前的DILIN预期 和回溯性数据库；2)专门招募疑似DILI的早期患者；3) 用非高加索族裔患者丰富现有的DILIN前瞻性和回溯性数据库；4) 评价化疗所致肝损伤的血清和遗传生物标记物，并确定褪黑素 预防化疗引起的肝损伤；以及5)快速识别新批准的 导致DILI病例意外集中的处方药和新的HDS配方。