Prospective Study of Lymphoproliferative Diseases
This study will help researchers learn more about non-Hodgkin's lymphoma and Hodgkin's lymphoma and how it is treated in Kenya. Researchers want to see if having certain viruses like Epstein Barr Virus (EBV), Human Immunodeficiency Virus (HIV), and Kaposi's Sarcoma Herpes Virus (KSHV) affects lymphoma. Patients in Kenya who agree to be in this study will let the resesarchers look at their medical record, follow their normal cancer care, and have blood drawn to look at different proteins and viruses. Researchers would also like to look at part of the original tumor that was taken out of each patient. Some of these samples will be stored at Kenyatta National Hospital and research will be done on them later. This study does not involve any change in treatment, but only allows the study team to follow how a patient in Kenya with lymphoma is treated.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Prospective Clinicopathological Cohort Study of Lymphoproliferative Diseases at Kenyatta National Hospital in Nairobi, Kenya|
- To determine the spectrum and natural history of lymphoproliferative disorders in Nairobi, Kenya [ Time Frame: 2.5 Years ] [ Designated as safety issue: No ]To determine the spectrum and natural history of lymophoproliferative disorders in Nairobi, Kenya by prospectively recruiting subjects with biopsy-proven malignant lymphoma including non-Hodgkin's and Hodgkin's lymphoma regardless of age, sex and HIV-serostatus (cohort study), who are seen at the Kenyatta National Hospital for treatment.
- To perform a comprehensive clinicopathological study in these subjects. [ Time Frame: 2.5 Years ] [ Designated as safety issue: No ]To perform a comprehensive clinicopathological study in these subjects with complete virological, immunophenotypic, and molecular characterization of retrieved tumor tissues and peripheral blood samples for purposes of identifying prognostic and predictive biomarkers of clinical outcome (i.e. treatment response, freedom from disease progression, and overall survival) in which to begin to frame pragmatic, risk-adapted therapeutic interventions suitable for the resource constrained setting in sub-Saharan Africa.
- Companion R01 proposal: Clinicopathological Cohort Study of EBV-Associated Lymphomas in Kenya [ Time Frame: To be submitted next 6 months to 1 year ] [ Designated as safety issue: No ]
- Aim 1: Determine the tissue biomarkers of EBV infection in AIDS-related lymphomas (ARL) in Kenya
- Aim 2: Compare the pattern of EBV persistence in patients with EBV+ and EBV- lymphoma
- Aim 3: Determine predictors of treatment outcome in AIDS-related lymphomas (ARL)
Biospecimen Retention: Samples With DNA
Tumor tissue, blood plasma and serum upon consent and suitability of sample preparation.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Comprehensive prospective cohort study of lymphoproliferative diseases in Nairobi, Kenya.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01704742
|United States, West Virginia|
|West Virginia University Mary Babb Randolph Cancer Center|
|Morgantown, West Virginia, United States, 26506|
|Kenyatta National Hospital (University of Nairobi)|
|Nairobi, Kenya, 00202|
|Principal Investigator:||Scot C Remick, MD||West Virginia University|
|Principal Investigator:||Walter O Mwanda, MD||Kenyatta National Hospital|