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Prospective Study of Lymphoproliferative Diseases

This study has been withdrawn prior to enrollment.
(Protocol not considered a clinical trial for registration purposes; no subjects enrolled to date pending further grant funding)
Sponsor:
Collaborator:
Kenyatta National Hospital
Information provided by (Responsible Party):
Scot Remick, MD, West Virginia University
ClinicalTrials.gov Identifier:
NCT01704742
First received: October 3, 2012
Last updated: January 3, 2014
Last verified: January 2014
History of Changes
  Purpose

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
Non-Hodgkin's Lymphoma
Hodgkin's Lymphoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Clinicopathological Cohort Study of Lymphoproliferative Diseases at Kenyatta National Hospital in Nairobi, Kenya

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by West Virginia University:

Primary Outcome Measures:
  • To determine the spectrum and natural history of lymphoproliferative disorders in Nairobi, Kenya [ Time Frame: 2.5 Years ] [ Designated as safety issue: No ]
    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:
  • To perform a comprehensive clinicopathological study in these subjects. [ Time Frame: 2.5 Years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    • 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.
Enrollment: 0
Study Start Date: October 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
No treatment

Detailed Description:

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

  Eligibility
Genders Eligible for Study:   Both
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.

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01704742

Locations
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
Sponsors and Collaborators
Scot Remick, MD
Kenyatta National Hospital
Investigators
Principal Investigator: Scot C Remick, MD West Virginia University
Principal Investigator: Walter O Mwanda, MD Kenyatta National Hospital
  More Information

No publications provided

Responsible Party: Scot Remick, MD, Director, Mary Babb Randolph Cancer Center, West Virginia University
ClinicalTrials.gov Identifier: NCT01704742     History of Changes
Other Study ID Numbers: WVU1411
Study First Received: October 3, 2012
Last Updated: January 3, 2014
Health Authority: United States: Institutional Review Board

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:
Hodgkin Disease
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Immune System Diseases
 Immunoproliferative Disorders
Lymphatic Diseases
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on February 26, 2015