Diagnostics & Laboratory Core

诊断

• 批准号: 10427344
• 负责人: Julie M Gastier-Foster
• 金额: $ 34.71万
• 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/10427344
• 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 care; clinical diagnosis; clinical diagnostics; diagnostic algorithm; experience; feasibility testing; 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） 为了管理疾病和患者的特定护理，准确和快速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， 免疫组化（IHC）和流式细胞术用于前瞻性患者。实验室检测监测 根据临床护理的要求，还将在这些实验室对患者进行CBCs、化学检查。 将进行增强，以测试在多个应用程序中使用标准化诊断算法的可行性。 在非洲建立一个更大的LMIC网络。 集中的病理学审查，特别是对于难以诊断的病例，对于大型项目来说是必不可少的， 如财团提议的那样。由于缺乏免疫组织化学（IHC）， 细胞组织学检查，NHL的错误分类在SSA中很常见。这一点在艾滋病中更为关键。 NHL的临床和病理学特征不典型的情况，例如高级别B细胞NHL DLBCL和BL之间中间体被认为更普遍。此外，非皮肤病例 卡波西肉瘤（KS）可能很难诊断。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提高以下能力： 更精确地诊断LMIC中的儿科癌症诊断。 该中心还将为研究提供样本处理、储存和运输的监督 包括在提案中。根据我们的经验，生物标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，这最大限度地减少了不必要的变化， 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 支持项目产生的所有生物标本的处理和实施 SSA研究中心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.协助所有生物标本的适当采集、处理、储存和运输 2.对儿科癌症进行常规组织学检查、免疫组织化学和流式细胞术 用于临床诊断和实验室检测的病例，以便对患者进行持续监测 3.支持实施、培训和协调中心病理审查， 病理学网络 4.通过支持现场验证，增强临床诊断算法， 关于其他方法的培训 5.协助发展核心（核心B）培训其他病理学家和实验室