COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Prospective Study of Lymphoproliferative Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01704742
Recruitment Status : Withdrawn (Protocol not considered a clinical trial for registration purposes; no subjects enrolled to date pending further grant funding)
First Posted : October 11, 2012
Last Update Posted : November 8, 2016
Kenyatta National Hospital
Information provided by (Responsible Party):
West Virginia University

Brief Summary:
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.

Condition or disease
Non-Hodgkin's Lymphoma Hodgkin's Lymphoma

Detailed Description:
Comprehensive prospective cohort study of lymphoproliferative diseases in Nairobi, Kenya.

Layout table for study information
Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Clinicopathological Cohort Study of Lymphoproliferative Diseases at Kenyatta National Hospital in Nairobi, Kenya

No treatment

Primary Outcome Measures :
  1. To determine the spectrum and natural history of lymphoproliferative disorders in Nairobi, Kenya [ Time Frame: 2.5 Years ]
    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.

Secondary Outcome Measures :
  1. To perform a comprehensive clinicopathological study in these subjects. [ Time Frame: 2.5 Years ]
    To perform a comprehensive clinicopathological study in these subjects with complete virological, immunophenotypic, and molecular characterization of retrieved tumor tissues and peripheral blood samples for purposes of identifying prognostic and predictive biomarkers of clinical outcome (i.e. treatment response, freedom from disease progression, and overall survival) in which to begin to frame pragmatic, risk-adapted therapeutic interventions suitable for the resource constrained setting in sub-Saharan Africa.

  2. Companion R01 proposal: Clinicopathological Cohort Study of EBV-Associated Lymphomas in Kenya [ Time Frame: To be submitted next 6 months to 1 year ]
    • Aim 1: Determine the tissue biomarkers of EBV infection in AIDS-related lymphomas (ARL) in Kenya
    • Aim 2: Compare the pattern of EBV persistence in patients with EBV+ and EBV- lymphoma
    • Aim 3: Determine predictors of treatment outcome in AIDS-related lymphomas (ARL)

Biospecimen Retention:   Samples With DNA
Tumor tissue, blood plasma and serum upon consent and suitability of sample preparation.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients at Kenyatta National Hospital in Kenya being treated for non-Hodgkin's lymphoma or Hodgkin's lymphoma.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01704742

Layout table for location information
United States, West Virginia
West Virginia University Mary Babb Randolph Cancer Center
Morgantown, West Virginia, United States, 26506
Kenyatta National Hospital (University of Nairobi)
Nairobi, Kenya, 00202
Sponsors and Collaborators
West Virginia University
Kenyatta National Hospital
Layout table for investigator information
Principal Investigator: Scot C Remick, MD West Virginia University
Principal Investigator: Walter O Mwanda, MD Kenyatta National Hospital
World Health Organization. Cancer. Fact Sheet No. 297, February 2011. Available at /fs297/en/index.html. Accessioned March 28, 2011.
World Health Organization. The Global Burden of Disease: 2004 Update. Geneva: WHO, 2008.
Ferlay J, Shin HR, Bray F, Forman D, Mathers C, and Parkin DM. Globocan 2008: cancer incidence and mortality worldwide. Lyon: International Agency for Research on Cancer, 2010. Available at: http://www.iarc/fr/. Accessioned March 28, 2011.
Remick SC. Responding to the global cancer burden through partnerships. In: Am. Soc. Clin. Oncol. Ed. Book 2009; 670-4.

Layout table for additonal information
Responsible Party: West Virginia University Identifier: NCT01704742    
Other Study ID Numbers: WVU1411
First Posted: October 11, 2012    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016
Keywords provided by West Virginia University:
Non-Hodgkin's Lymphoma
Hodgkin's Lymphoma
Epstein Barr Virus (EBV)
Human Immunodeficiency Virus (HIV)
Kaposi's Sarcoma Herpes Virus (KSHV)
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma, Non-Hodgkin
Hodgkin Disease
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases