Clinical trial NCT01704742: Prospective Study of Lymphoproliferative Diseases
Official title: A Prospective Clinicopathological Cohort Study of Lymphoproliferative Diseases at Kenyatta National Hospital in Nairobi, Kenya
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Non-Hodgkin's Lymphoma
Hodgkin's Lymphoma
Keywords: Non-Hodgkin's Lymphoma
Hodgkin's Lymphoma
Kenya
Epstein Barr Virus (EBV)
Human Immunodeficiency Virus (HIV)
Kaposi's Sarcoma Herpes Virus (KSHV)
Lead sponsor: West Virginia University
Sponsor class: OTHER
Collaborators: name: Kenyatta National Hospital
First posted: 2012-10-11
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients at Kenyatta National Hospital in Kenya being treated for non-Hodgkin's lymphoma or Hodgkin's lymphoma.

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: To determine the spectrum and natural history of lymphoproliferative disorders in Nairobi, Kenya
timeFrame: 2.5 Years
Secondary outcomes:
measure: To perform a comprehensive clinicopathological study in these subjects.
timeFrame: 2.5 Years
measure: Companion R01 proposal: Clinicopathological Cohort Study of EBV-Associated Lymphomas in Kenya
timeFrame: To be submitted next 6 months to 1 year
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University Mary Babb Randolph Cancer Center
state: West Virginia
city: Nairobi
country: Kenya
facility: Kenyatta National Hospital (University of Nairobi)
Study officials:
affiliation: West Virginia University
name: Scot C Remick, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kenyatta National Hospital
name: Walter O Mwanda, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: World 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.
citation: World Health Organization. The Global Burden of Disease: 2004 Update. Geneva: WHO, 2008.
citation: 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.
citation: Remick SC. Responding to the global cancer burden through partnerships. In: Am. Soc. Clin. Oncol. Ed. Book 2009; 670-4.