Study Stopped
Protocol not considered a clinical trial for registration purposes; no subjects enrolled to date pending further grant funding
Prospective Study of Lymphoproliferative Diseases
A Prospective Clinicopathological Cohort Study of Lymphoproliferative Diseases at Kenyatta National Hospital in Nairobi, Kenya
1 other identifier
observational
N/A
2 countries
2
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.
Trial Health
Trial Health Score
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2 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2012
CompletedFirst Posted
Study publicly available on registry
October 11, 2012
CompletedNovember 8, 2016
November 1, 2016
October 3, 2012
November 4, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the spectrum and natural history of lymphoproliferative disorders in Nairobi, Kenya
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.
2.5 Years
Secondary Outcomes (2)
To perform a comprehensive clinicopathological study in these subjects.
2.5 Years
Companion R01 proposal: Clinicopathological Cohort Study of EBV-Associated Lymphomas in Kenya
To be submitted next 6 months to 1 year
Study Arms (1)
No treatment
Eligibility Criteria
Patients at Kenyatta National Hospital in Kenya being treated for non-Hodgkin's lymphoma or Hodgkin's lymphoma.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- West Virginia Universitylead
- Kenyatta National Hospitalcollaborator
Study Sites (2)
West Virginia University Mary Babb Randolph Cancer Center
Morgantown, West Virginia, 26506, United States
Kenyatta National Hospital (University of Nairobi)
Nairobi, 00202, Kenya
Related Publications (5)
Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.
PMID: 21296855BACKGROUNDWorld Health Organization. Cancer. Fact Sheet No. 297, February 2011. Available at http://www.who.int/mediacentre/factsheets /fs297/en/index.html. Accessioned March 28, 2011.
BACKGROUNDWorld Health Organization. The Global Burden of Disease: 2004 Update. Geneva: WHO, 2008.
BACKGROUNDFerlay 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.
BACKGROUNDRemick SC. Responding to the global cancer burden through partnerships. In: Am. Soc. Clin. Oncol. Ed. Book 2009; 670-4.
BACKGROUND
Biospecimen
Tumor tissue, blood plasma and serum upon consent and suitability of sample preparation.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Scot C Remick, MD
West Virginia University
- PRINCIPAL INVESTIGATOR
Walter O Mwanda, MD
Kenyatta National Hospital