Epidemiology of Burkitt Lymphoma in East-African Children and Minors

Burkitt's lymphoma

EMBLEM is a multi-country and multi-year case-control study of childhood Burkitt’s lymphoma in Uganda, Tanzania and Kenya.

To evaluate:

• The association of malaria-resistance genes with endemic Burkitt's lymphoma,
• Other host genetic polymorphisms associated with BL using genome-wide association methods, and
• The role of EBV genetic variants in BL.

Epidemiologists or others interested in collaboration should contact Dr. Sam Mbulaiteye for more information. Collaborations with scientifically and ethically appropriate investigators are welcomed.

The EMBLEM study will enroll 1,500 histologically confirmed cases of Burkitt’s lymphoma from 2010 to 2015. Two controls per case (for a total of 3,000) will be enrolled from representative villages in the regions where cases originated.

Data collection will include a questionnaire administered by an EMBLEM staff interviewer to elicit exposure related to birth, residence of the child, parentage, socioeconomic status, household exposure, childhood illness and vaccination. Laboratory test results will be collected from the subjects and physical examination measurements will be taken, including the anatomic site involved for cases and height and weight for both cases and controls.

Participants will contribute blood which is divided into various components for performing CBC, erythrocyte sedimentation rate, liver/renal function tests, malaria smear, malaria rapid test, HIV serology. Additionally, a specimen will be banked for future testing. A saliva specimen will also be collected and banked for future testing. Cases will contribute histological specimens in addition to bone marrow aspirate and lumbar puncture

To insure integration of the process across institutions, we created Standard Operating Procedures (SOPs) at the beginning of the project. Quality Assurance/Quality Control visits were also performed periodically. Conference calls and field staff research meetings are held weekly throughout the course of the study to monitor adherence with study procedures and to assess milestones. Monitoring reports are submitted numerous times during the year to report on the status of the office, laboratory, data management, specimen collection, and case/control enrollment. Detailed study manuals have been developed to cover procedures for research physicians, laboratory personnel, and data processing center staff. Study progress is also reported to a group of investigators from the Division of Cancer Epidemiology and Genetics of NCI to assess study activity and recommended technical, scientific or management changes when appropriate.

The study has undergone formal ethical review and received approval from the Institutional Review Board (IRB) at the National Cancer Institute. The study has also undergone review and approval by the formal ethical bodies of the participating hospitals and coordinating centers in Uganda, Tanzania, and Kenya. The IRB’s in Uganda, Tanzania, Kenya and the United States revisit the study on a yearly basis. Study procedures are reviewed with all participants prior to enrollment into the study. Participants are required to provide signed informed consent indicating an understanding of the study, its procedures, risks and benefits. At any time, participants may refuse to participate in any part of the study. All study procedures are conducted using standard operating procedures (SOPs) to maximize patient and staff safety, and to insure the scientific integrity of the results. Data are stored without patient identifiers.

EMBLEM is the largest study of childhood Burkitt’s lymphoma in Africa. Unlike previous studies, it is a population-based, multi-country and multi-year case-control study with an extensive biospecimen collection component collection to be population based. EMBLEM will address the etiologic questions raised in previous Burkitt’s lymphoma studies, as well as, focusing on future work such as genome-wide association and genetic polymorphism.

EMBLEM is the largest study of childhood Burkitt’s lymphoma in Africa. Unlike previous studies, it is a population-based, multi-country and multi-year case-control study with an extensive biospecimen collection component. EMBLEM will address the etiologic questions raised in previous Burkitt’s lymphoma studies, as well as, focus on future work such as genome-wide association and genetic polymorphism.

Only children (0-15 years) with or without Burkitt’s lymphoma from specified regions of Uganda, Kenya, and Tanzania can be enrolled. This is because the scientific design of the study requires the children, with or without BL, to have been heavily exposed to malaria infection.

• Infections and Immunoepidemiology Branch, National Cancer Institute (NCI)
  Intramural research focusing on cancer risk related to infections and immune disturbance
• Office of HIV and AIDS Malignancy, National Cancer Institute (NCI)
  Coordinates research on HIV and cancer.
• Non-Hodgkin Lymphoma, National Cancer Institute (NCI)
  Provides information on the Non-Hodgkin Lymphoma