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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) National Cancer Institute (NCI) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001120 |
The purpose of this study is to find out why cancers develop in HIV-positive patients.
Cancer is a leading cause of death in AIDS patients. Common cancers in HIV-infected patients include Kaposi's sarcoma (KS) and non-Hodgkin's lymphoma (NHL), a cancer of the immune system. Risk factors include certain chemicals, viruses, and perhaps even anti-HIV drugs. Doctors would like to find out which risk factors are most important and how they relate to cancer in AIDS patients.
Condition |
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Sarcoma, Kaposi Lymphoma, Non-Hodgkin HIV Infections Lymphoma, AIDS-Related |
Study Type: | Observational |
Official Title: | Oncogenic Viral Pathogenesis and Cancer Risk Factors Among Patients With the Acquired Immunodeficiency Syndrome: A Prospective Cohort Study |
Estimated Enrollment: | 5000 |
AIDS-associated malignancy represents a model system for investigations of carcinogenesis. There are few human conditions in which cancer rates are of the magnitude they are in HIV infection. While studies have investigated pre-cancer markers in HIV-infected patients, they have not correlated these markers with tumor samples. This study contributes to understanding oncogenesis of HIV-associated malignancies by establishing a collection of tumors linked with pre-cancer sera and lymphocyte specimens, as well as prospective questionnaire data.
At study entry, patients receive a comprehensive physical exam. Clinic staff interview the patient to collect data regarding medication history (particularly antiretroviral exposure), diet, occupational history, substance abuse, and sexual practices. This information is used to identify behavioral and environmental factors contributing to oncogenesis. In addition, baseline blood samples are analyzed for HHV-8 and EBV levels, anti-EBV and anti-HHV-8 antibodies, CD23, Th2 cytokines, tumor growth factors, chromosomal translocations associated with NHL, and other potential predictors of malignancy. At Month 6 and annually thereafter, patient records are abstracted for data on vital status, AIDS-defining illnesses, medications, and most recent CD4+ T cell and HIV RNA levels. At Years 1, 2, and 3, patients undergo physical exams and blood tests for malignancy surveillance. Any malignancies are biopsied and analyzed for oncogene identification and virology. The medical records of patients who die on study are reviewed to determine the cause of death and to rule out unreported cancer. No treatment is provided by this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
You may be eligible for this trial if you:
Exclusion Criteria
You will not be eligible for this trial if you:
United States, California | |
San Francisco Gen Hosp | |
San Francisco, California, United States, 941102859 | |
Stanford Univ Med Ctr | |
Stanford, California, United States, 943055107 | |
San Mateo AIDS Program / Stanford Univ | |
Stanford, California, United States, 943055107 | |
Marin County Specialty Clinic | |
San Rafael, California, United States, 94903 | |
Willow Clinic | |
Menlo Park, California, United States, 94025 | |
United States, Hawaii | |
Univ of Hawaii | |
Honolulu, Hawaii, United States, 96816 | |
United States, Indiana | |
Indiana Univ Hosp | |
Indianapolis, Indiana, United States, 462025250 | |
United States, Louisiana | |
Charity Hosp / Tulane Univ Med School | |
New Orleans, Louisiana, United States, 70112 | |
Tulane Univ School of Medicine | |
New Orleans, Louisiana, United States, 70112 | |
United States, Maryland | |
Johns Hopkins Hosp | |
Baltimore, Maryland, United States, 21287 | |
United States, Massachusetts | |
Harvard (Massachusetts Gen Hosp) | |
Boston, Massachusetts, United States, 02114 | |
United States, New York | |
Univ of Rochester Medical Center | |
Rochester, New York, United States, 14642 | |
Mem Sloan - Kettering Cancer Ctr | |
New York, New York, United States, 10021 | |
Bellevue Hosp / New York Univ Med Ctr | |
New York, New York, United States, 10016 | |
SUNY / Erie County Med Ctr at Buffalo | |
Buffalo, New York, United States, 14215 | |
St Mary's Hosp (Univ of Rochester/Infectious Diseases) | |
Rochester, New York, United States, 14642 | |
United States, North Carolina | |
Univ of North Carolina | |
Chapel Hill, North Carolina, United States, 275997215 | |
Duke Univ Med Ctr | |
Durham, North Carolina, United States, 27710 | |
United States, Ohio | |
Case Western Reserve Univ | |
Cleveland, Ohio, United States, 44106 | |
Univ of Cincinnati | |
Cincinnati, Ohio, United States, 452670405 | |
Ohio State Univ Hosp Clinic | |
Columbus, Ohio, United States, 432101228 | |
MetroHealth Med Ctr | |
Cleveland, Ohio, United States, 441091998 | |
United States, Washington | |
Univ of Washington | |
Seattle, Washington, United States, 98104 |
Study Chair: | David A. Wohl | Univ of North Carolina |
Study Chair: | Ann C. Collier | Univ of Washington |
Study Chair: | William G. Powderly | |
Principal Investigator: | Charles S. Rabkin |
Study ID Numbers: | ACTG A5035 |
Study First Received: | November 2, 1999 |
Last Updated: | September 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00001120 |
Health Authority: | United States: Federal Government |
Prospective Studies Sarcoma, Kaposi Herpesvirus 4, Human Acquired Immunodeficiency Syndrome Cohort Studies Risk Factors |
Lymphoma, AIDS-Related Antibodies, Viral Lymphoproliferative Disorders Viral Load Herpesvirus, Kaposi Sarcoma-Associated Translocation (Genetics) |
Sexually Transmitted Diseases, Viral Malignant mesenchymal tumor Soft tissue sarcomas Lymphoma, B-Cell Neoplasms, Connective and Soft Tissue Kaposi sarcoma Lymphoma, AIDS-Related Retroviridae Infections Lymphoma Immunoglobulins Lymphoma, AIDS-related Immunoproliferative Disorders Sarcoma, Kaposi |
Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Herpesviridae Infections Virus Diseases Lymphatic Diseases Antibodies HIV Infections B-cell lymphomas Sexually Transmitted Diseases Sarcoma DNA Virus Infections Lymphoproliferative Disorders Lymphoma, Non-Hodgkin |
Neoplasms RNA Virus Infections Pathologic Processes Disease Neoplasms by Histologic Type Slow Virus Diseases |
Immune System Diseases Syndrome Neoplasms, Vascular Tissue Lentivirus Infections Infection |