Developing a clinical cohort of histopathologically characterized lymphoma

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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.