Improving the Accuracy of Diagnosis of Cancer in Children with HIV Infection

提高 HIV 感染儿童癌症诊断的准确性

基本信息

批准号：
10223902
负责人：
Julie M Gastier-Foster
金额：
$ 12.87万
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/10223902
关键词：
AIDS related cancer AIDS/HIV problem Address Adult Africa South of the Sahara Algorithms Antibodies Archives Biological Assay Biopsy Botswana Burkitt Lymphoma Chest Child Childhood Clinical Clinical Pathology Color Cytogenetics Development Diagnosis Diagnostic Diagnostic Procedure Ensure Evidence based treatment Fine needle aspiration biopsy Flow Cytometry Foundations Goals Gold HIV HIV Infections HIV diagnosis Health Personnel Hematoxylin and Eosin Staining Method Hospitals Human Resources Image Immunohistochemistry Incisional Biopsy Infection Infrastructure Laboratories Left Lesion Link Lymphoma Malawi Malignant Childhood Neoplasm Malignant Neoplasms Molecular Morphology Needle biopsy procedure Operative Surgical Procedures Opportunistic Infections Pathologist Pathology Peripheral Predictive Value Preparation Procedures Process Protocols documentation Recording of previous events Reporting Reproducibility Research Sedation procedure Site Specificity Stains Standardization Superficial Lesion System Tanzania Testing Time Tissues Training Translational Research Uganda Ultrasonography United States base cancer diagnosis cancer therapy cost design diagnostic accuracy diagnostic assay diagnostic biomarker diagnostic platform experience improved infection related cancer leukemia/lymphoma lymph nodes lymphadenopathy molecular diagnostics novel novel diagnostics novel strategies pediatric human immunodeficiency virus recruit research facility skills skin lesion success treatment research treatment site tumor virtual

项目摘要

Project 2: Improving the Accuracy of Diagnosis of Cancer in Children with HIV Infection The goal of Project 2 is to evaluate and implement novel strategies that are reproducible and sustainable across treatment sites in sub-Saharan Africa (SSA) to improve real-time diagnosis of HIV-associated pediatric cancers, because this is a prerequisite for evidence-based treatment and clinical/translational research. Diagnosis of cancer in children in SSA is a major challenge because of scarcity of local skilled personnel, facilities for obtaining tissue biopsies, and laboratory platforms for pathology analysis. The result is that for many children with suspected cancer a diagnosis is made based on clinical features only. If a biopsy is obtained, morphological examination using Hematoxylin & Eosin (H&E) stain is often the only test performed. In our study of 324 with HIV infection and diagnosed with KS at BIPAI centers in Uganda, Malawi, Tanzania and Botswana from 2008 – 2014, 141 (43%) of the children were diagnosed based on clinical history and examination only. The overarching aim of this project is to implement and evaluate harmonized diagnostic strategies in PARCA sites. Aim 1: Evaluate the adequacy of biopsies and diagnostic accuracy of the current Global HOPE Uganda diagnostic strategy for pediatric cancer tumors. We will retrospectively assess the proportion of adequate biopsies, and repeat or escalation to open surgical biopsy among 400 children with HIV-associated cancers. To determine the accuracy of the current diagnostic strategy, we will perform gold-standard diagnostic assays by United States standards on archived FFPE tissues from these 400 cases. Aim 2: Determine the feasibility of standardizing the diagnostic algorithm across multiple sites by implementing a similar algorithm in Malawi. We will implement a similar diagnostic approach in Malawi by training medical personnel to use a similar biopsy strategy and expanding the flow cytometry and IHC antibody panels to mimic those performed in Uganda. To ensure accuracy and consistency across sites in preparation for implementation of standardized cancer treatment and research protocols across SSA sites, we will implement a virtual pathology platform to enable sharing and central review of images. The virtual pathology network will also serve as a platform for ongoing training of pediatric pathologists and technicians. Aim 3: Improve accuracy of cancer diagnosis at SSA sites by designing, testing, and implementing novel diagnostic methods. We will test and validate novel molecular assays of established diagnostic biomarkers to improve timeliness and specificity of the diagnosis using platforms and procedures that are sustainable in the SSA setting. Consideration will be given to cost, complexity, and turnaround time.

项目2：提高HIV感染儿童癌症诊断的准确性项目 2 的目标是评估和实施可重复且可持续的新颖策略撒哈拉以南非洲 (SSA) 的各个治疗地点，以改善艾滋病毒相关儿科的实时诊断癌症，因为这是循证治疗和临床/转化研究的先决条件。由于当地技术人员稀缺，SSA 儿童癌症的诊断是一项重大挑战，用于获取组织活检的设施和用于病理分析的实验室平台。许多疑似患有癌症的儿童仅根据临床特征做出诊断。获得后，使用苏木精和伊红 (H&E) 染色进行形态学检查通常是唯一进行的测试。我们对乌干达、马拉维、坦桑尼亚 BIPAI 中心的 324 名 HIV 感染者和诊断为 KS 的研究进行了研究 2008 年至 2014 年期间，在博茨瓦纳和博茨瓦纳，有 141 名儿童（43%）根据既往临床和该项目的总体目标是实施和评估统一诊断。 PARCA 站点的策略。目标 1：评估乌干达当前 Global HOPE 的活检充分性和诊断准确性我们将回顾性评估儿童癌症肿瘤的诊断策略。对 400 名患有 HIV 相关癌症的儿童进行活检，并重复或升级至开放手术活检。为了确定当前诊断策略的准确性，我们将进行黄金标准诊断测定根据美国标准对这 400 例存档的 FFPE 组织进行分析。目标 2：确定跨多个站点标准化诊断算法的可行性在马拉维实施类似的算法我们将通过以下方式在马拉维实施类似的诊断方法。培训医务人员使用类似的活检策略并扩展流式细胞术和 IHC 抗体小组模仿在乌干达进行的小组，以确保各个地点准备工作的准确性和一致性。为了在 SSA 站点实施标准化癌症治疗和研究方案，我们将实施虚拟病理平台以实现图像共享和集中审查。该网络还将作为儿科病理学家和技术人员持续培训的平台。目标 3：通过设计、测试和实施提高 SSA 站点癌症诊断的准确性我们将测试和验证已建立的诊断的新分子测定方法。生物标志物，使用以下平台和程序来提高诊断的及时性和特异性将考虑成本、复杂性和周转时间。