Prospective Study of Lymphoproliferative Diseases
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ClinicalTrials.gov 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Withdrawn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
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Condition or disease |
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Non-Hodgkin's Lymphoma Hodgkin's Lymphoma |
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 |

Group/Cohort |
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No treatment |
- 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.
- 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.
- 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

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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.

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 ClinicalTrials.gov identifier (NCT number): NCT01704742
United States, West Virginia | |
West Virginia University Mary Babb Randolph Cancer Center | |
Morgantown, West Virginia, United States, 26506 | |
Kenya | |
Kenyatta National Hospital (University of Nairobi) | |
Nairobi, Kenya, 00202 |
Principal Investigator: | Scot C Remick, MD | West Virginia University | |
Principal Investigator: | Walter O Mwanda, MD | Kenyatta National Hospital |
Publications:
Responsible Party: | West Virginia University |
ClinicalTrials.gov Identifier: | NCT01704742 History of Changes |
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 Kenya |
Epstein Barr Virus (EBV) Human Immunodeficiency Virus (HIV) Kaposi's Sarcoma Herpes Virus (KSHV) |
Additional relevant MeSH terms:
Lymphoma Lymphoma, Non-Hodgkin Hodgkin Disease Lymphoproliferative Disorders Neoplasms by Histologic Type |
Neoplasms Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |