Nctid:
NCT00001120
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000163", "term"=>"Acquired Immunodeficiency Syndrome"}, {"id"=>"D012514", "term"=>"Sarcoma, Kaposi"}, {"id"=>"D008223", "term"=>"Lymphoma"}, {"id"=>"D012509", "term"=>"Sarcoma"}, {"id"=>"D008228", "term"=>"Lymphoma, Non-Hodgkin"}, {"id"=>"D016483", "term"=>"Lymphoma, AIDS-Related"}], "ancestors"=>[{"id"=>"D009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D008232", "term"=>"Lymphoproliferative Disorders"}, {"id"=>"D008206", "term"=>"Lymphatic Diseases"}, {"id"=>"D007160", "term"=>"Immunoproliferative Disorders"}, {"id"=>"D007154", "term"=>"Immune System Diseases"}, {"id"=>"D018204", "term"=>"Neoplasms, Connective and Soft Tissue"}, {"id"=>"D015658", "term"=>"HIV Infections"}, {"id"=>"D000086982", "term"=>"Blood-Borne Infections"}, {"id"=>"D003141", "term"=>"Communicable Diseases"}, {"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D015229", "term"=>"Sexually Transmitted Diseases, Viral"}, {"id"=>"D012749", "term"=>"Sexually Transmitted Diseases"}, {"id"=>"D016180", "term"=>"Lentivirus Infections"}, {"id"=>"D012192", "term"=>"Retroviridae Infections"}, {"id"=>"D012327", "term"=>"RNA Virus Infections"}, {"id"=>"D014777", "term"=>"Virus Diseases"}, {"id"=>"D000091662", "term"=>"Genital Diseases"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D007153", "term"=>"Immunologic Deficiency Syndromes"}, {"id"=>"D012897", "term"=>"Slow Virus Diseases"}, {"id"=>"D006566", "term"=>"Herpesviridae Infections"}, {"id"=>"D004266", "term"=>"DNA Virus Infections"}, {"id"=>"D009383", "term"=>"Neoplasms, Vascular Tissue"}, {"id"=>"D016393", "term"=>"Lymphoma, B-Cell"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M11220", "name"=>"Lymphoma", "asFound"=>"Lymphoma", "relevance"=>"HIGH"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M15327", "name"=>"Sarcoma", "asFound"=>"Sarcoma", "relevance"=>"HIGH"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M11222", "name"=>"Lymphoma, Non-Hodgkin", "asFound"=>"Lymphoma, Non-Hodgkin", "relevance"=>"HIGH"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "asFound"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"HIGH"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M11225", "name"=>"Lymphoproliferative Disorders", "relevance"=>"LOW"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M15332", "name"=>"Sarcoma, Kaposi", "asFound"=>"Sarcoma, Kaposi", "relevance"=>"HIGH"}, {"id"=>"M18888", "name"=>"Lymphoma, AIDS-Related", "asFound"=>"Lymphoma, AIDS-Related", "relevance"=>"HIGH"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M11203", "name"=>"Lymphatic Diseases", "relevance"=>"LOW"}, {"id"=>"M10206", "name"=>"Immunoproliferative Disorders", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}, {"id"=>"M20350", "name"=>"Neoplasms, Connective and Soft Tissue", "relevance"=>"LOW"}, {"id"=>"M2593", "name"=>"Blood-Borne Infections", "relevance"=>"LOW"}, {"id"=>"M15558", "name"=>"Sexually Transmitted Diseases", "relevance"=>"LOW"}, {"id"=>"M17933", "name"=>"Sexually Transmitted Diseases, Viral", "relevance"=>"LOW"}, {"id"=>"M18640", "name"=>"Lentivirus Infections", "relevance"=>"LOW"}, {"id"=>"M15026", "name"=>"Retroviridae Infections", "relevance"=>"LOW"}, {"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M15149", "name"=>"RNA Virus Infections", "relevance"=>"LOW"}, {"id"=>"M2876", "name"=>"Genital Diseases", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M15700", "name"=>"Slow Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M9643", "name"=>"Herpesviridae Infections", "relevance"=>"LOW"}, {"id"=>"M7442", "name"=>"DNA Virus Infections", "relevance"=>"LOW"}, {"id"=>"M12328", "name"=>"Neoplasms, Vascular Tissue", "relevance"=>"LOW"}, {"id"=>"M18828", "name"=>"Lymphoma, B-Cell", "relevance"=>"LOW"}, {"id"=>"T3543", "name"=>"Lymphosarcoma", "asFound"=>"Lymphoma", "relevance"=>"HIGH"}, {"id"=>"T5284", "name"=>"Soft Tissue Sarcoma", "relevance"=>"LOW"}, {"id"=>"T3199", "name"=>"Kaposi Sarcoma", "asFound"=>"Sarcoma, Kaposi", "relevance"=>"HIGH"}, {"id"=>"T640", "name"=>"B-cell Lymphoma", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Blood and Lymph Conditions", "abbrev"=>"BC15"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M4225", "name"=>"Antibodies", "relevance"=>"LOW"}, {"id"=>"M10184", "name"=>"Immunoglobulins", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "enrollmentInfo"=>{"count"=>5000}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2006-05", "lastUpdateSubmitDate"=>"2008-09-11", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2008-09-12", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["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)"], "conditions"=>["Sarcoma, Kaposi", "Lymphoma, Non-Hodgkin", "HIV Infections", "Lymphoma, AIDS-Related"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to find out why cancers develop in HIV-positive patients.\n\nCancer 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.", "detailedDescription"=>"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.\n\nAt 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."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nYou may be eligible for this trial if you:\n\n* Are HIV-positive.\n* Have a CD4+ cell count of 200 cells/mm3 or below.\n* Are 18 years of age or older.\n\nExclusion Criteria\n\nYou will not be eligible for this trial if you:\n\n* Are not available for follow-up for at least 3 years."}, "identificationModule"=>{"nctId"=>"NCT00001120", "briefTitle"=>"A Study of Patients With AIDS Syndrome", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"Oncogenic Viral Pathogenesis and Cancer Risk Factors Among Patients With the Acquired Immunodeficiency Syndrome: A Prospective Cohort Study", "orgStudyIdInfo"=>{"id"=>"ACTG A5035"}}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"94025", "city"=>"Menlo Park", "state"=>"California", "country"=>"United States", "facility"=>"Willow Clinic", "geoPoint"=>{"lat"=>37.45383, "lon"=>-122.18219}}, {"zip"=>"941102859", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"San Francisco Gen Hosp", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"94903", "city"=>"San Rafael", "state"=>"California", "country"=>"United States", "facility"=>"Marin County Specialty Clinic", "geoPoint"=>{"lat"=>37.97353, "lon"=>-122.53109}}, {"zip"=>"943055107", "city"=>"Stanford", "state"=>"California", "country"=>"United States", "facility"=>"San Mateo AIDS Program / Stanford Univ", "geoPoint"=>{"lat"=>37.42411, "lon"=>-122.16608}}, {"zip"=>"943055107", "city"=>"Stanford", "state"=>"California", "country"=>"United States", "facility"=>"Stanford Univ Med Ctr", "geoPoint"=>{"lat"=>37.42411, "lon"=>-122.16608}}, {"zip"=>"96816", "city"=>"Honolulu", "state"=>"Hawaii", "country"=>"United States", "facility"=>"Univ of Hawaii", "geoPoint"=>{"lat"=>21.30694, "lon"=>-157.85833}}, {"zip"=>"462025250", "city"=>"Indianapolis", "state"=>"Indiana", "country"=>"United States", "facility"=>"Indiana Univ Hosp", "geoPoint"=>{"lat"=>39.76838, "lon"=>-86.15804}}, {"zip"=>"70112", "city"=>"New Orleans", "state"=>"Louisiana", "country"=>"United States", "facility"=>"Charity Hosp / Tulane Univ Med School", "geoPoint"=>{"lat"=>29.95465, "lon"=>-90.07507}}, {"zip"=>"70112", "city"=>"New Orleans", "state"=>"Louisiana", "country"=>"United States", "facility"=>"Tulane Univ School of Medicine", "geoPoint"=>{"lat"=>29.95465, "lon"=>-90.07507}}, {"zip"=>"21287", "city"=>"Baltimore", "state"=>"Maryland", "country"=>"United States", "facility"=>"Johns Hopkins Hosp", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}, {"zip"=>"02114", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Harvard (Massachusetts Gen Hosp)", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"14215", "city"=>"Buffalo", "state"=>"New York", "country"=>"United States", "facility"=>"SUNY / Erie County Med Ctr at Buffalo", "geoPoint"=>{"lat"=>42.88645, "lon"=>-78.87837}}, {"zip"=>"10016", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Bellevue Hosp / New York Univ Med Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10021", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Mem Sloan - Kettering Cancer Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"14642", "city"=>"Rochester", "state"=>"New York", "country"=>"United States", "facility"=>"St Mary's Hosp (Univ of Rochester/Infectious Diseases)", "geoPoint"=>{"lat"=>43.15478, "lon"=>-77.61556}}, {"zip"=>"14642", "city"=>"Rochester", "state"=>"New York", "country"=>"United States", "facility"=>"Univ of Rochester Medical Center", "geoPoint"=>{"lat"=>43.15478, "lon"=>-77.61556}}, {"zip"=>"275997215", "city"=>"Chapel Hill", "state"=>"North Carolina", "country"=>"United States", "facility"=>"Univ of North Carolina", "geoPoint"=>{"lat"=>35.9132, "lon"=>-79.05584}}, {"zip"=>"27710", "city"=>"Durham", "state"=>"North Carolina", "country"=>"United States", "facility"=>"Duke Univ Med Ctr", "geoPoint"=>{"lat"=>35.99403, "lon"=>-78.89862}}, {"zip"=>"452670405", "city"=>"Cincinnati", "state"=>"Ohio", "country"=>"United States", "facility"=>"Univ of Cincinnati", "geoPoint"=>{"lat"=>39.12713, "lon"=>-84.51435}}, {"zip"=>"44106", "city"=>"Cleveland", "state"=>"Ohio", "country"=>"United States", "facility"=>"Case Western Reserve Univ", "geoPoint"=>{"lat"=>41.4995, "lon"=>-81.69541}}, {"zip"=>"441091998", "city"=>"Cleveland", "state"=>"Ohio", "country"=>"United States", "facility"=>"MetroHealth Med Ctr", "geoPoint"=>{"lat"=>41.4995, "lon"=>-81.69541}}, {"zip"=>"432101228", "city"=>"Columbus", "state"=>"Ohio", "country"=>"United States", "facility"=>"Ohio State Univ Hosp Clinic", "geoPoint"=>{"lat"=>39.96118, "lon"=>-82.99879}}, {"zip"=>"98104", "city"=>"Seattle", "state"=>"Washington", "country"=>"United States", "facility"=>"Univ of Washington", "geoPoint"=>{"lat"=>47.60621, "lon"=>-122.33207}}], "overallOfficials"=>[{"name"=>"David A. Wohl", "role"=>"STUDY_CHAIR", "affiliation"=>"Univ of North Carolina"}, {"name"=>"Ann C. Collier", "role"=>"STUDY_CHAIR", "affiliation"=>"Univ of Washington"}, {"name"=>"William G. Powderly", "role"=>"STUDY_CHAIR"}, {"name"=>"Charles S. Rabkin", "role"=>"PRINCIPAL_INVESTIGATOR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "collaborators"=>[{"name"=>"National Cancer Institute (NCI)", "class"=>"NIH"}]}}}
