Diagnostics & Laboratory Core

诊断

• 批准号: 10657485
• 负责人: Julie M Gastier-Foster
• 金额: $ 34.49万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 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/10657485
• 关键词: Africa; Africa South of the Sahara; Algorithms; B-Cell NonHodgkins Lymphoma; Caring; Characteristics; Chemistry; Clinical; Collection; Development; Diagnosis; Diagnostic; Disease; Education; Ensure; Flow Cytometry; Funding; HIV; HIV/AIDS; 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 care; clinical diagnosis; clinical diagnostics; diagnostic algorithm; experience; feasibility testing; improved; infection related cancer; large cell Diffuse non-Hodgkin' s lymphoma; low and middle-income countries; pediatric human immunodeficiency virus; prospective; rapid diagnosis; research study; virtual

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） 为了治疗疾病和患者特异性护理，对小儿癌的准确和快速诊断至关重要。 核心包括乌干达和马拉维的临床实验室，该实验室将提供组织学评论， 预期患者的免疫组织化学（IHC）和流式细胞仪。实验室测试以监测 患者（CBC，化学）也将根据临床护理的要求在这些实验室中进行。 将进行增强，以测试使用多个标准化诊断算法的可行性 站点和实施虚拟病理以进行中央审查，以准备非洲更大的LMIC网络。 集中病理审查，尤其是对于难以诊断的病例，对于大规模项目至关重要， 例如财团提出的。由于无法获得免疫组织化学（IHC）和 细胞组织学综述，NHLS的错误分类在SSA中很常见。这在艾滋病毒中更为关键 NHL的临床和病理特征的设置是非典型的，例如高级B细胞NHL DLBCL和BL之间的中级被认为更为普遍。此外，非态病例 Kaposi的肉瘤（KS）可能很难诊断。该核心提供的病理服务以及 在整个资金期间，对算法的改进将大大提高能力 在LMIC中，更精确地诊断儿科癌症诊断。 核心还将为研究研究提供样品处理，存储和运输的监督 包括在提案中。根据我们的经验，对生物测量的集中处理可确保它们是 根据适当的标准化协议处理，该协议可最大程度地减少不良变异性 稍后分析样品。诊断和实验室核心的责任（核心D）包括 支持处理从项目产生的所有生物测量并实施 SSA站点的小儿癌诊断算法的改进 为了实现这些目标，诊断和实验室核心的目的是： 1。协助所有生物测量的适当收集，加工，存储和运输 2。进行常规的组织学综述，免疫组织化学和小儿癌的流式细胞仪 临床诊断和实验室测试的病例正在进行的患者监测 3。支持使用虚拟的中央病理评论的实施，培训和协调 病理网络 4。通过支持现场验证和 对其他方法的培训 5。协助发展核心（核心B）进行其他病理学家和实验室的教育