Nctid:
NCT00001876
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D011658", "term"=>"Pulmonary Fibrosis"}, {"id"=>"D005355", "term"=>"Fibrosis"}], "ancestors"=>[{"id"=>"D010335", "term"=>"Pathologic Processes"}, {"id"=>"D008171", "term"=>"Lung Diseases"}, {"id"=>"D012140", "term"=>"Respiratory Tract Diseases"}, {"id"=>"D017563", "term"=>"Lung Diseases, Interstitial"}], "browseLeaves"=>[{"id"=>"M8485", "name"=>"Fibrosis", "asFound"=>"Fibrosis", "relevance"=>"HIGH"}, {"id"=>"M11168", "name"=>"Lung Diseases", "relevance"=>"LOW"}, {"id"=>"M19813", "name"=>"Lung Diseases, Interstitial", "relevance"=>"LOW"}, {"id"=>"M4476", "name"=>"Arthritis", "relevance"=>"LOW"}, {"id"=>"M4480", "name"=>"Arthritis, Rheumatoid", "relevance"=>"LOW"}, {"id"=>"M14512", "name"=>"Pulmonary Fibrosis", "asFound"=>"Pulmonary Fibrosis", "relevance"=>"HIGH"}, {"id"=>"M17400", "name"=>"Vascular Diseases", "relevance"=>"LOW"}, {"id"=>"M15045", "name"=>"Rheumatic Diseases", "relevance"=>"LOW"}, {"id"=>"M6323", "name"=>"Collagen Diseases", "relevance"=>"LOW"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"Musculoskeletal Diseases", "abbrev"=>"BC05"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>132}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1999-04-05", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2022-09", "completionDateStruct"=>{"date"=>"2007-12-11", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2022-09-27", "studyFirstSubmitDate"=>"1999-11-03", "studyFirstSubmitQcDate"=>"1999-11-03", "lastUpdatePostDateStruct"=>{"date"=>"2022-09-29", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"1999-11-04", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"2005-11-09", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Prevalence", "timeFrame"=>"Ongoing", "description"=>"To estimate the prevalence of pulmonary fibrosis in individuals with rheumatoid arthritis. Subjects will include patients that have rheumatoid arthritis-only."}, {"measure"=>"Natural History", "timeFrame"=>"Ongoing", "description"=>"To define the natural history of pulmonary fibrosis associated with rheumatoid arthritis in a prospective, longitudinal study."}]}, "conditionsModule"=>{"keywords"=>["Interstitial Lung Disease", "Collagen Vascular Disease", "Extracellular Matrix", "Pulmonary Function", "DTPA Lung Clearance Scan", "Natural History"], "conditions"=>["Pulmonary Fibrosis"]}, "referencesModule"=>{"seeAlsoLinks"=>[{"url"=>"https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_1999-HG-0056.html", "label"=>"NIH Clinical Center Detailed Web Page"}]}, "descriptionModule"=>{"briefSummary"=>"Pulmonary fibrosis (PF) is a condition in which the lungs of a patient become scarred and fibrous. It has been known to occur in as many as 40% of patients diagnosed with rheumatoid arthritis (RA). The cause of the pulmonary fibrosis in patients with RA is unknown.\n\nPatients participating in this study will undergo a series of tests and examinations before and throughout the study. The tests include blood and urine tests, electrical measures of heart function (ECG), chest x-rays, CAT scans, nuclear medicine scans, breathing tests, exercise tests, and fiberoptic bronchoscopy.\n\nThe goals of this study are to:\n\n1. Estimate how common pulmonary fibrosis is in patients with rheumatoid arthritis,\n2. Describe the natural course of pulmonary fibrosis in patients with rheumatoid arthritis,\n3. Estimate the survival rate of patients with pulmonary fibrosis and rheumatoid arthritis, and\n4. Learn more about the factors that contribute to the development or progression fibrotic lung disease....", "detailedDescription"=>"Pulmonary fibrosis is an extra-articular manifestation of rheumatoid arthritis whose etiology remains uncertain. Although the clinical course of many individuals with this disorder can mimic that observed in patients with idiopathic pulmonary fibrosis, the natural history of fibrotic lung disease associated with rheumatoid arthritis remains largely undefined. It is the intent of this clinical protocol to (1) estimate the prevalence of pulmonary fibrosis in individuals with rheumatoid arthritis, (2) define the natural history of pulmonary fibrosis in patients with rheumatoid arthritis, (3) estimate the survival rate of individuals with pulmonary fibrosis and rheumatoid arthritis, and (4) examine pulmonary physiologic, radiologic, and biochemical markers that predict the development or progression of fibrotic lung disease."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"21 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Subjects will include individuals with (1) rheumatoid arthritis and biopsy-proven pulmonary fibrosis, (2) rheumatoid arthritis-only, and (3) biopsy-proven idiopathic pulmonary fibrosis-only.@@@", "healthyVolunteers"=>false, "eligibilityCriteria"=>"* INCLUSION CRITERIA:\n\nNon-smokers (never smoked or no smoking within the previous 2 years) who are 21 years of age or older with any of the following:\n\nRheumatoid arthritis with biopsy-proven pulmonary fibrosis or;\n\nRheumatoid arthritis only, or;\n\nBiopsy-proven idiopathic pulmonary fibrosis.\n\nEXCLUSION CRITERIA:\n\nForced expiratory volume in one second (FEV1) less than 1L.\n\nInhalational exposure to fibrogenic fibers or dusts (e.g., asbestos, silica, coal, beryllium).\n\nChronic cardiopulmonary disorders other than pulmonary fibrosis.\n\nOther collagen vascular disorders (e.g., systemic lupus erythematosus, scleroderma, polymyositis, mixed connective tissue disease).\n\nNon-rheumatoid arthritis.\n\nViral infections associated with pulmonary fibrosis (e.g., hepatitis B, hepatitis C, human immunodeficiency virus).\n\nUncorrectable bleeding diathesis.\n\nPregnancy or lactation."}, "identificationModule"=>{"nctId"=>"NCT00001876", "briefTitle"=>"Lung Disease Associated With Rheumatoid Arthritis", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"Pulmonary Fibrosis Associated With Rheumatoid Arthritis: Definition of the Natural History of Disease", "orgStudyIdInfo"=>{"id"=>"990056"}, "secondaryIdInfos"=>[{"id"=>"99-HG-0056"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Combo", "description"=>"Patients with rheumatoid arthritis and biopsy-proven pulmonary fibrosis."}, {"label"=>"pulmonary fibrosis", "description"=>"Patients with biobsy-proven idiopathic pulmonary fibrosis only."}, {"label"=>"rheumatoid arthritis", "description"=>"Patients with rheumatoid arthritis only."}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"20892", "city"=>"Bethesda", "state"=>"Maryland", "country"=>"United States", "facility"=>"National Institutes of Health Clinical Center", "geoPoint"=>{"lat"=>38.98067, "lon"=>-77.10026}}], "overallOfficials"=>[{"name"=>"Bernadette R Gochuico, M.D.", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"National Human Genome Research Institute (NHGRI)"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Human Genome Research Institute (NHGRI)", "class"=>"NIH"}, "collaborators"=>[{"name"=>"National Heart, Lung, and Blood Institute (NHLBI)", "class"=>"NIH"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
