Developing a clinical cohort of histopathologically characterized lymphoma

描述(由申请人提供)：这是为北卡罗来纳大学教堂山分校的传染病内科医生和内科肿瘤学家萨蒂什·戈帕尔博士申请福格蒂国际中心K01国际研究科学家发展奖。戈帕尔博士正在资源有限的环境下，在艾滋病毒相关淋巴瘤和淋巴瘤治疗领域确立自己的年轻研究员地位。这一K01奖项将为戈帕尔博士提供必要的支持，以实现以下目标：(1)成为在资源有限的情况下进行临床试验的专家；(2)发展多学科、远程合作的技能；(3)在高级研究设计和生物统计学方法方面获得更多经验；以及(4)学习与健康相关的生活质量研究的基础知识。为了实现这些目标，戈帕尔博士组建了一个指导团队，成员包括美国的主要导师托马斯·谢伊博士，他是血液和肿瘤科的临时负责人，是血液系统恶性肿瘤临床合作试验的国际领先者，以及 马拉维的一位主要导师，马拉维北卡罗来纳大学项目的临床主任和撒哈拉以南非洲临床试验专家Mina Hosseiniour博士，以及三位共同导师；病毒致癌机制专家Blossom Damania博士和Dirk Dittmer博士，他们尤其对艾滋病毒恶性肿瘤感兴趣；以及William Miller博士，分析方法专家，指导年轻研究人员实现研究独立性。淋巴瘤是撒哈拉以南非洲最常见的癌症之一，发病率迅速上升。戈帕尔博士的研究将侧重于马拉维疑似淋巴瘤患者的准确组织病理学诊断(AIM 1)、疑似淋巴瘤患者的临床和实验室数据的系统收集(AIM 2)以及在当地条件下接受治疗的确诊血液病患者的纵向随访(AIM 3)。在目标1中，戈帕尔博士将对至少200名连续登记的疑似淋巴瘤患者进行核心淋巴结活组织检查。在目标2中，戈帕尔博士将在登记和淋巴结活检时收集患者的相关临床和实验室数据，并将这些数据与最终的组织病理学诊断相关联。在目标3中，戈帕尔博士将对确诊为恶性血液病的患者进行为期两年的系统的纵向评估，以评估对治疗的反应、与治疗相关的毒性、治疗成本以及与健康相关的生活质量(HRQOL)措施。本提案中概述的研究将构成撒哈拉以南非洲淋巴瘤治疗多中心临床试验的基础，该试验将在职业发展奖励期结束前在R01申请中提出。 公共卫生相关性：在撒哈拉以南非洲，淋巴瘤的负担正在迅速增加，目前的诊断和治疗战略是不够的。更好地了解淋巴瘤的临床和组织病理学特征，对于开发在资源有限的情况下在当地条件下可行的有效治疗方法至关重要。

DESCRIPTION (provided by applicant): This is an application for a Fogarty International Center K01 International Research Scientist Development Award for Dr. Satish Gopal, an infectious disease physician and medical oncologist at the University of North Carolina at Chapel Hill. Dr. Gopal is establishing himself as a young investigator in the areas of HIV-associated lymphoma and lymphoma treatment in resource-limited settings. This K01 award will provide Dr. Gopal with the support necessary to accomplish the following goals: (1) to become an expert in clinical trial conduct in resource-limited settings; (2) to develop skills in multidisciplinary, long-distance collaboration; (3) to gain additional experience in advanced study design and biostatistical methods; and (4) to learn fundamentals of health-related quality of life research. To achieve these goals, Dr. Gopal has assembled a mentoring team comprised of a US primary mentor, Dr. Thomas Shea, Interim Chief of the Division of Hematology and Oncology, an international leader in collaborative clinical trials in hematologic malignancies, and a Malawi primary mentor, Dr. Mina Hosseinipour, Clinical Director of UNC Project-Malawi and an expert in clinical trials in sub-Saharan Africa, as well as three co-mentors; Drs. Blossom Damania and Dirk Dittmer, experts in pathogenic mechanisms of viral oncogenesis with particular interest in HIV malignancies; and Dr. William Miller, an expert in analytic methods and mentoring young investigators toward research independence. Lymphoma is one of the most common cancers in sub-Saharan Africa with rapidly increasing incidence. Dr. Gopal's research will focus on accurate histopathologic diagnosis among patients with suspected lymphoma in Malawi (Aim 1), systematic collection of clinical and laboratory data among patients with suspected lymphoma (Aim 2), and longitudinal follow-up among those with confirmed hematologic malignancies receiving treatment under local conditions (Aim 3). In Aim 1, Dr. Gopal will perform core lymph node biopsies on at least 200 consecutively enrolled patients with suspected lymphoma. In Aim 2, Dr. Gopal will collect relevant clinical and laboratory data among patients at the time of enrollment and lymph node biopsy, and correlate these data with final histopathologic diagnosis. In Aim 3, Dr. Gopal will perform systematic, longitudinal assessments for 2 years among those with confirmed hematologic malignancies to evaluate response to therapy, treatment-related toxicities, costs of treatment, and health-related quality o life (HRQOL) measures. The studies outlined in this proposal will form the basis for a multicenter clinical trial of lymphoma treatment in sub-Saharan Africa to be proposed in an R01 application before the end of the career development award period. PUBLIC HEALTH RELEVANCE: The burden of lymphoma is rapidly increasing in sub-Saharan Africa, and current diagnostic and treatment strategies are inadequate. Improved understanding of the clinical and histopathologic features of lymphoma is critical to developing effective treatments which are feasible under local conditions in resource- limited settings.