Developing a clinical cohort of histopathologically characterized lymphoma

描述（由申请人提供）：这是一份Fogarty国际中心K 01国际研究科学家发展奖的申请，申请人是查佩尔山北卡罗来纳州大学的传染病医生和医学肿瘤学家Satish Gopal博士。Gopal博士在资源有限的环境中成为艾滋病毒相关淋巴瘤和淋巴瘤治疗领域的年轻研究者。该K 01奖将为Gopal博士提供必要的支持，以实现以下目标：（1）成为资源有限环境中临床试验的专家;（2）培养多学科，远程合作的技能;（3）获得先进的研究设计和生物统计方法的额外经验;（4）学习健康相关生活质量研究的基础知识。为了实现这些目标，Gopal博士组建了一个由美国主要导师托马斯谢伊博士组成的指导团队，他是血液学和肿瘤学部门的临时主任，是血液恶性肿瘤合作临床试验的国际领导者， 一位马拉维的主要导师，Mina Hosseinipour博士，马拉维研究项目的临床主任和撒哈拉以南非洲临床试验专家，以及三位共同导师;开花Damania和Dirk Dittmer博士，病毒肿瘤发生的致病机制专家，特别是对艾滋病毒恶性肿瘤感兴趣; William米勒博士，分析方法专家，指导年轻研究人员走向研究独立。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。Gopal博士的研究将集中在马拉维疑似淋巴瘤患者的准确组织病理学诊断（目标1），疑似淋巴瘤患者的临床和实验室数据的系统收集（目标2），以及在当地条件下接受治疗的确诊恶性血液病患者的纵向随访（目标3）。在目标1中，Gopal博士将对至少200例连续入组的疑似淋巴瘤患者进行核心淋巴结活检。在目标2中，Dr. Gopal将在入组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组织病理学诊断相关联。在目标3中，Dr. Gopal将对确诊的恶性血液病患者进行为期2年的系统性纵向评估，以评价治疗反应、治疗相关毒性、治疗成本和健康相关生活质量（HRQOL）指标。本提案中概述的研究将构成在撒哈拉以南非洲进行淋巴瘤治疗多中心临床试验的基础，该临床试验将在职业发展奖结束前在R 01申请中提出。

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.