Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-25 @ 4:10 AM
NCT ID:
NCT01196520
Eligibility Criteria:
* 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.
Healthy Volunteers:
True
Sex:
ALL
Maximum Age:
15 Years
Study:
NCT01196520
Study Brief:
Protocol Section:
NCT01196520