Prospective Study of Lymphoproliferative Diseases

Non-Hodgkin's Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01704742
• Other study ID #: WVU1411
• Status: Withdrawn
• Phase: N/A
• First received: October 3, 2012
• Last updated: November 4, 2016

Study information

• Verified date: November 2016
• Source: West Virginia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin's Lymphoma
• Lymphoma
• Lymphoma, Non-Hodgkin
• Lymphoproliferative Disorders
• Non-Hodgkin's Lymphoma

Locations

Country	Name	City	State
Kenya	Kenyatta National Hospital (University of Nairobi)	Nairobi
United States	West Virginia University Mary Babb Randolph Cancer Center	Morgantown	West Virginia

Sponsors (2)

Lead Sponsor	Collaborator
West Virginia University	Kenyatta National Hospital

Countries where clinical trial is conducted

United States,  Kenya, 

References & Publications (5)

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.

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. Erratum in: CA Cancer J Clin. 2011 Mar-Apr;61(2):134. — View Citation

Remick SC. Responding to the global cancer burden through partnerships. In: Am. Soc. Clin. Oncol. Ed. Book 2009; 670-4.

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.

World Health Organization. The Global Burden of Disease: 2004 Update. Geneva: WHO, 2008.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To perform a comprehensive clinicopathological study in these subjects.	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.	2.5 Years	No
Secondary	Companion R01 proposal: Clinicopathological Cohort Study of EBV-Associated Lymphomas in Kenya	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)	To be submitted next 6 months to 1 year	No