Nctid:
NCT00001869
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-17"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000018192", "term"=>"Lymphangioleiomyomatosis"}, {"id"=>"D000018231", "term"=>"Leiomyomatosis"}], "ancestors"=>[{"id"=>"D000008203", "term"=>"Lymphangiomyoma"}, {"id"=>"D000018190", "term"=>"Lymphatic Vessel Tumors"}, {"id"=>"D000009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000054973", "term"=>"Perivascular Epithelioid Cell Neoplasms"}, {"id"=>"D000018204", "term"=>"Neoplasms, Connective and Soft Tissue"}, {"id"=>"D000008232", "term"=>"Lymphoproliferative Disorders"}, {"id"=>"D000008206", "term"=>"Lymphatic Diseases"}, {"id"=>"D000007160", "term"=>"Immunoproliferative Disorders"}, {"id"=>"D000007154", "term"=>"Immune System Diseases"}, {"id"=>"D000007889", "term"=>"Leiomyoma"}, {"id"=>"D000009379", "term"=>"Neoplasms, Muscle Tissue"}], "browseLeaves"=>[{"id"=>"M15415", "name"=>"Sclerosis", "relevance"=>"LOW"}, {"id"=>"M13920", "name"=>"Pneumothorax", "relevance"=>"LOW"}, {"id"=>"M17152", "name"=>"Tuberous Sclerosis", "relevance"=>"LOW"}, {"id"=>"M20338", "name"=>"Lymphangioleiomyomatosis", "asFound"=>"Lymphangioleiomyomatosis", "relevance"=>"HIGH"}, {"id"=>"M20377", "name"=>"Leiomyomatosis", "asFound"=>"Leiomyomatosis", "relevance"=>"HIGH"}, {"id"=>"M11200", "name"=>"Lymphangiomyoma", "relevance"=>"LOW"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M27983", "name"=>"Perivascular Epithelioid Cell Neoplasms", "relevance"=>"LOW"}, {"id"=>"M20350", "name"=>"Neoplasms, Connective and Soft Tissue", "relevance"=>"LOW"}, {"id"=>"M11225", "name"=>"Lymphoproliferative Disorders", "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"=>"M10901", "name"=>"Leiomyoma", "relevance"=>"LOW"}, {"id"=>"M25846", "name"=>"Myofibroma", "relevance"=>"LOW"}, {"id"=>"T5751", "name"=>"Tuberous Sclerosis Complex", "relevance"=>"LOW"}, {"id"=>"T3526", "name"=>"Lymphangioleiomyomatosis", "asFound"=>"Lymphangioleiomyomatosis", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Diseases and Abnormalities at or Before Birth", "abbrev"=>"BC16"}, {"name"=>"Blood and Lymph Conditions", "abbrev"=>"BC15"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M14245", "name"=>"Progesterone", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "enrollmentInfo"=>{"count"=>400}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1998-12"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2003-04", "completionDateStruct"=>{"date"=>"2003-04"}, "lastUpdateSubmitDate"=>"2008-03-03", "studyFirstSubmitDate"=>"1999-11-03", "studyFirstSubmitQcDate"=>"1999-11-03", "lastUpdatePostDateStruct"=>{"date"=>"2008-03-04", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"1999-11-04", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Progesterone", "Pulmonary Function Tests", "Pneumothorax", "Oopherectomy", "High Resolution CT", "Tuberous Sclerosis Complex", "Lymphangioleiomyomatosis (LAM)"], "conditions"=>["Leiomyomatosis"]}, "referencesModule"=>{"references"=>[{"pmid"=>"8024411", "type"=>"BACKGROUND", "citation"=>"Abdulla M, Bui HX, del Rosario AD, Wolf BC, Ross JS. Renal angiomyolipoma. DNA content and immunohistochemical study of classic and multicentric variants. Arch Pathol Lab Med. 1994 Jul;118(7):735-9."}, {"pmid"=>"2367651", "type"=>"BACKGROUND", "citation"=>"Aberle DR, Hansell DM, Brown K, Tashkin DP. Lymphangiomyomatosis: CT, chest radiographic, and functional correlations. Radiology. 1990 Aug;176(2):381-7. doi: 10.1148/radiology.176.2.2367651."}, {"pmid"=>"1000470", "type"=>"BACKGROUND", "citation"=>"Basset F, Soler P, Marsac J, Corrin B. Pulmonary lymphangiomyomatosis: three new cases studied with electron microscopy. Cancer. 1976 Dec;38(6):2357-66. doi: 10.1002/1097-0142(197612)38:63.0.co;2-a."}]}, "descriptionModule"=>{"briefSummary"=>"Pulmonary lymphoangioleiomyomatosis (LAM) is a rare destructive lung disease typically affecting women of childbearing age. Currently, there is no effective therapy for the disease and the prognosis is poor.\n\nIn order to better study this disease, the National Heart, Lung, and Blood Institute (NHLBI) has developed a registry to keep an official record of patients diagnosed with LAM. This research project will collect data from 6 health care centers as well as outside physicians. Researchers hope to provide valuable information about the rate of lung destruction and quality of life in patients with LAM.\n\nPatients participating in this study will be followed for 5 years. Tissue collected from these patients may contribute to the development of future studies on the disease processes of LAM.", "detailedDescription"=>"LAM is a rare disease that predominantly affects women of child-bearing age. To study in more detail this rare disease, this multi-center project will establish a registry of persons with LAM. By combining data from 6 centers and outside physicians, this study may yield valuable information regarding the rate of decline in pulmonary function and quality of life in individuals with LAM. These patients will be followed over a five-year period. Tissue collected from study participants may facilitate future studies into the molecular basis of LAM."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"Informed consent must be obtained from the patient.\n\nPatients must be female.\n\nPatients must be age 18 or older.\n\nPatients with prevalent and incident cases are eligible.\n\nPatients with the presence or absence of underlying diagnosis or evidence of Tuberous Sclerosis Complex (TSC) are eligible.\n\nPatients must have a diagnosis of LAM confirmed by any of the following criteria:\n\nLung biopsy (transbronchial, surgical, transthoracic) judged to be diagnostic by the Tissue Core pathologists;\n\nOR\n\nBiopsy of lymph node or other mass judged to be diagnostic by the Tissue Core pathologists;\n\nOR\n\nHigh resolution CT scan of the chest which is judged to be diagnostic of LAM with a high degree of certainty by all three of the expert radiologists making up the Imaging Core.\n\nPatients may be enrolled in other protocols."}, "identificationModule"=>{"nctId"=>"NCT00001869", "briefTitle"=>"Official Record of Patients Diagnosed With Lymphangioleiomyomatosis (LAM)", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"Lymphangioleiomyomatosis (LAM) Registry", "orgStudyIdInfo"=>{"id"=>"990020"}, "secondaryIdInfos"=>[{"id"=>"99-H-0020"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"20892", "city"=>"Bethesda", "state"=>"Maryland", "country"=>"United States", "facility"=>"National Heart, Lung and Blood Institute (NHLBI)", "geoPoint"=>{"lat"=>38.98067, "lon"=>-77.10026}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Heart, Lung, and Blood Institute (NHLBI)", "class"=>"NIH"}}}}
