Status:
COMPLETED
Epidemiology of Burkitt Lymphoma in East Africa Children or Minors (EMBLEM)
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Lymphoma, Non-Hodgkin
Malaria
Eligibility:
All Genders
Up to 15 years
Brief Summary
Burkitt lymphoma (BL) is an aggressive monoclonal B-cell malignancy that is rare (sporadic) worldwide, but is 100-fold more common (endemic) in equatorial Africa, particularly among children. Epstein-...
Detailed Description
Burkitt lymphoma (BL) is an aggressive monoclonal B-cell malignancy that is rare (sporadic) worldwide, but is 100-fold more common (endemic) in equatorial Africa, particularly among children. Epstein-...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- For case subjects:
- Newly diagnosed child with BL. New newly diagnosed means not more than 1 month since diagnosis, to minimize bias from mortality after diagnosis.
- Not initiated BL specific treatment.
- Age 0 through 15 years at diagnosis.
- Residing in a pre-defined geographic area for at least 4 months prior to onset of BL-related symptoms. The catchment geographic area will be defined in the Study Manual as districts for each region.
- Diagnosis based on local histology or cytology report.
- For control subjects:
- Age 0-15 years.
- Residing in a defined geographic area for at least 4 months.
- EXCLUSION CRITERIA:
- For case subjects:
- Not residing within the pre-defined geographic area for at least 4 months before onset of BL-related symptoms.
- Clinically unstable condition; they will be stabilized first.
- Initiated BL treatment.
- Wrong diagnosis.
- Refusal or are inability to consent.
- For control subjects:
- Mild clinical malaria (fever 37.5 degrees Celcius and a thick blood smear positive for malaria).
- Any severe illness requiring immediate admission to hospital, e.g. acute respiratory infection, diarrhea with dehydration, snake bites or fractures.
- Any cancer.
- Not a usual resident of an eligible geographic area.
- Non-consent.
Exclusion
Key Trial Info
Start Date :
May 25 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 21 2020
Estimated Enrollment :
4893 Patients enrolled
Trial Details
Trial ID
NCT01196520
Start Date
May 25 2010
End Date
May 21 2020
Last Update
May 22 2020
Active Locations (6)
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1
Bugando Medical Center
Mwanza, Tanzania
2
Shirati Health, Educational, and Development Foundation
Shirati, Tanzania
3
St.Mary's Hospital Lacor
Gulu, Uganda
4
Kuluva Hospital (Arua)
Kampala, Uganda