Prospective Study of Lymphoproliferative Diseases
Status: | Withdrawn |
---|---|
Conditions: | Lymphoma, Hematology |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | Any |
Updated: | 4/21/2016 |
A Prospective Clinicopathological Cohort Study of Lymphoproliferative Diseases at Kenyatta National Hospital in Nairobi, Kenya
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.
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.
Comprehensive prospective cohort study of lymphoproliferative diseases in Nairobi, Kenya.
Inclusion Criteria:
- All subjects regardless of age, sex or HIV serostatus must have biopsy-proven
non-Hodgkin's (NHL), including primary effusion lymphoma, Hodgkin's lymphoma (HD) or
other lymphoproliferative disorder (e.g., Castleman's disease) with measurable or
evaluable stage I through IV disease.
[Note: Lymphomas will be categorized on the basis of current WHO classification scheme,
but it is recognized that initial pathological categorization at time of study enrollment
will more than likely be classified or graded as low-, intermediate-, or high-grade
lymphoma by Working Formulation criteria. This is the current standard of practice in
Kenya.]
- All subjects must receive some form of systemic chemotherapy. Subjects not receiving
chemotherapy of any kind are not eligible. Subjects must not have had any prior
chemotherapy for lymphoma.
- Subjects may have received prior radiotherapy for localized stage I or stage II
disease that is clearly documented to have progressed beyond initial radiotherapy
ports.
- All subjects must give written informed consent to participate on study. In Kenya, a
child is considered < 18 years of age and an adult ≥ 18 years of age. All children
will have their parental or legal guardian provide consent.. Children between the
ages of 7 and < 18 years old should be given the opportunity to provide their assent.
For children between the ages of 7 and 11 years old this should be done using the
parental consent form assent statement. For children > 11 years old assent should be
documented using the IRB approved assent form.
Exclusion Criteria:
- Subjects who do not fulfill the criteria as listed in Sections 3.1.1 through 3.1.4
are ineligible.
- Subjects who received prior chemotherapy (i.e., first-line treatment) or are not
receiving any chemotherapy for their non-Hodgkin's (NHL) or Hodgkin's lymphoma (HD)
are ineligible.
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