Diagnostics & Laboratory Core

诊断

基本信息

批准号：
10223900
负责人：
Julie M Gastier-Foster
金额：
$ 33.96万
依托单位：
BAYLOR COLLEGE OF MEDICINE
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-07-25 至 2025-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10223900
关键词：
AIDS/HIV problem Africa Africa South of the Sahara Algorithms B-Cell NonHodgkins Lymphoma Caring Characteristics Chemistry Clinical Clinical Pathology Collection Development Diagnosis Diagnostic Disease Education Ensure Flow Cytometry Funding HIV Histologic Immunohistochemistry Kaposi Sarcoma Laboratories Laboratory Personnel Malawi Malignant Childhood Neoplasm Medicine Methodology Pathologist Pathology Patient Monitoring Patients Preparation Process Protocols documentation Research Sampling Services Shipping Site Standardization Testing Training Uganda Utilization Review Validation accurate diagnosis cancer diagnosis clinical Diagnosis clinical care clinical diagnostics experience feasibility testing infection related cancer large cell Diffuse non-Hodgkin&apos s lymphoma low and middle-income countries pediatric human immunodeficiency virus prospective rapid diagnosis research study virtual

项目摘要

Diagnostic & Laboratory Core (Core D) To administer disease- and patient-specific care, accurate and rapid diagnosis of pediatric cancer is critical. The core includes the clinical laboratories in Uganda and Malawi, which will provide histological review, immunohistochemistry (IHC), and flow cytometry for prospective patients. Laboratory testing to monitor patients (CBCs, chemistry) will also be performed in these laboratories, as required for clinical care. Enhancements will be made to test the feasibility of using standardized diagnostic algorithms across multiple sites and implementing virtual pathology for central review, in preparation for a larger LMIC network in Africa. Centralized pathology review, especially for difficult to diagnose cases, is imperative for large-scale projects, such as those proposed by the Consortium. Due to lack of access to immunohistochemistry (IHC) and cytohistological review, misclassification of NHLs is common in SSA. This is even more critical in the HIV setting where the clinical and pathology characteristics of NHL are atypical e.g. high-grade B-cell NHL intermediate between DLBCL and BL are thought to be more prevalent. Further, non-cutaneous cases of Kaposi's sarcoma (KS) can be difficult to diagnose. The pathology services offered by this Core, and the improvements made to the algorithm over the course of the funding period, will greatly enhance the ability to more precisely diagnosis pediatric cancer diagnosis in the LMICs. The core will also provide oversight of sample processing, storage, and shipping for the research studies included in the proposal. In our experience, centralized processing of biospecimens ensures that they are processed according to appropriate standardized protocols, which minimizes unwanted variability when the samples are later analyzed. The responsibilities of the Diagnostic & Laboratory Core (Core D) include support for the processing of all biospecimens generated from the Projects and for implementing improvements in the pediatric cancer diagnosis algorithm at the SSA sites To accomplish these objectives, the Aims of the Diagnostic & Laboratory Core are: 1. To assist with the appropriate collection, processing, storage, and shipping of all biospecimens 2. To perform routine histologic review, immunohistochemistry, and flow cytometry of pediatric cancer cases for clinical diagnosis and laboratory testing for the ongoing monitoring of patients 3. To support the implementation, training, and coordination of central pathology review utilizing a virtual pathology network 4. To implement enhancements to clinical diagnostic algorithms by supporting onsite validation and training on additional methodologies 5. To assist the Developmental Core (Core B) in the education of additional pathologists and laboratory

诊断和实验室核心（核心 D）为了实施针对特定疾病和患者的护理，准确、快速地诊断儿科癌症至关重要。核心包括乌干达和马拉维的临床实验室，将提供组织学审查、针对潜在患者的免疫组织化学 (IHC) 和流式细胞术。实验室测试监测根据临床护理的需要，患者（CBC、化学）也将在这些实验室进行。将进行增强功能以测试跨多个领域使用标准化诊断算法的可行性站点并实施虚拟病理学进行中央审查，为非洲更大的中低收入国家网络做好准备。集中病理学审查，特别是对于难以诊断的病例，对于大型项目来说是必要的，例如联盟提出的建议。由于缺乏免疫组织化学（IHC）和根据细胞组织学检查，NHL 的错误分类在 SSA 中很常见。这对于艾滋病毒来说更为重要 NHL 的临床和病理学特征不典型的环境，例如高级别 B 细胞 NHL 介于 DLBCL 和 BL 之间的中间型被认为更为普遍。此外，非皮肤病例卡波西肉瘤 (KS) 很难诊断。该核心提供的病理学服务，以及在资助期间对算法进行的改进将大大增强更准确地诊断中低收入国家的儿科癌症诊断。该核心还将监督研究的样品处理、储存和运输包括在提案中。根据我们的经验，生物样本的集中处理可确保它们根据适当的标准化协议进行处理，这可以最大限度地减少不必要的变化随后对样品进行分析。诊断和实验室核心（核心 D）的职责包括支持处理项目产生的所有生物样本并实施 SSA 站点儿科癌症诊断算法的改进为了实现这些目标，诊断和实验室核心的目标是： 1. 协助所有生物样本的适当收集、处理、储存和运输 2. 对儿科癌症进行常规组织学检查、免疫组化和流式细胞术用于临床诊断和实验室检测的病例，以持续监测患者 3. 利用虚拟平台支持中央病理审查的实施、培训和协调病理网 4. 通过支持现场验证和验证来增强临床诊断算法其他方法的培训 5. 协助发展核心（核心B）教育更多病理学家和实验室