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A Prospective Clinicopathological Cohort Study of Lymphoproliferative Diseases at Kenyatta National Hospital in Nairobi, Kenya

Open (Enrolling)
Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma

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Trial Information

A Prospective Clinicopathological Cohort Study of Lymphoproliferative Diseases at Kenyatta National Hospital in Nairobi, Kenya

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

- 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

- 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.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

To determine the spectrum and natural history of lymphoproliferative disorders in Nairobi, Kenya

Outcome Description:

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.

Outcome Time Frame:

2.5 Years

Safety Issue:


Principal Investigator

Scot C Remick, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

West Virginia University


United States: Institutional Review Board

Study ID:




Start Date:

October 2012

Completion Date:

April 2014

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Hodgkin's Lymphoma
  • Non-Hodgkin's Lymphoma
  • Hodgkin's Lymphoma
  • Kenya
  • Epstein Barr Virus (EBV)
  • Human Immunodeficiency Virus (HIV)
  • Kaposi's Sarcoma Herpes Virus (KSHV)
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoproliferative Disorders



West Virginia University Mary Babb Randolph Cancer CenterMorgantown, West Virginia  26506