Prospective Study of Lymphoproliferative Diseases

NCT ID: NCT01704742

Last Updated: 2016-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Brief Summary

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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

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

Conditions

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Non-Hodgkin's Lymphoma Hodgkin's Lymphoma

Keywords

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Non-Hodgkin's Lymphoma Hodgkin's Lymphoma Kenya Epstein Barr Virus (EBV) Human Immunodeficiency Virus (HIV) Kaposi's Sarcoma Herpes Virus (KSHV)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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No treatment

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kenyatta National Hospital

OTHER_GOV

Sponsor Role collaborator

West Virginia University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Scot C Remick, MD

Role: PRINCIPAL_INVESTIGATOR

West Virginia University

Walter O Mwanda, MD

Role: PRINCIPAL_INVESTIGATOR

Kenyatta National Hospital

Locations

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West Virginia University Mary Babb Randolph Cancer Center

Morgantown, West Virginia, United States

Site Status

Kenyatta National Hospital (University of Nairobi)

Nairobi, , Kenya

Site Status

Countries

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United States Kenya

References

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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.

Reference Type BACKGROUND
PMID: 21296855 (View on PubMed)

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.

Reference Type BACKGROUND

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

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

Reference Type BACKGROUND

Other Identifiers

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WVU1411

Identifier Type: -

Identifier Source: org_study_id