[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT01776398":3,"trial-entities:NCT01776398":112,"trial-summary:NCT01776398":117},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":24,"study_type":37,"primary_purpose":38,"phases":39,"enrollment_info":40,"interventions":43,"primary_outcomes":44,"secondary_outcomes":49,"sex":53,"minimum_age":54,"maximum_age":38,"healthy_volunteers":14,"eligibility_criteria":55,"std_ages":78,"locations":81,"central_contacts":96,"overall_officials":99,"references":103,"see_also_links":111},"NCT01776398","1204012331","Collection of Airway, Blood and\u002For Urine Specimens From Subjects for Research Studies","RECRUITING","2028-12","2025-11","2025-11-14","2012-08-29","Weill Medical College of Cornell University","OTHER",true,"The purpose of this study is to obtain biologic materials from the blood, airways and\u002For urine of normal individuals and individuals with lung disease. The normal are used to establish a set of normal ranges for various parameters. These provide control information when compared to individuals with various pulmonary diseases, and will help in understanding of the etiology and pathogenesis of various lung diseases. The underlying hypothesis is that the pathologic morphological changes in the airway epithelium must be preceded by changes in the gene expression pattern of the airway epithelium and potentially in macrophages.","This is a protocol to obtain blood, urine and\u002For airway specimens from normal individuals and individuals with lung disorders in order to carry out laboratory studies looking at genetic expression, gene transfer, infection, proteins, human genes, and to store specimens for future genetic studies. Specimens collected may include blood, urine and airway samples (nasal, airway brushing, biopsy and\u002For washings) from consenting subjects. Subjects will include both individuals diagnosed with lung disease and healthy control subjects. The purpose of this study is to obtain biologic materials from the blood, airways and\u002For urine of normal individuals and individuals with lung disease. The normal are used to establish a set of normal ranges for various parameters. These provide control information when compared to individuals with various pulmonary diseases, and will help in understanding of the etiology and pathogenesis of various lung diseases. The investigators will use bronchoscopy (inserting a scope into the lungs) to obtain airway cells by brushing, biopsy and\u002For washings in individuals with lung disease and in healthy controls. By studying those cells, the investigators hope to learn more about the specific causes of lung disease, how lung disease manifests and progresses, and how lung disease can be treated.",[18,19,20,21,22,23],"Chronic Obstructive Pulmonary Disease (COPD)","Smoking","Smoking Cessation","Idiopathic Pulmonary Fibrosis (IPF)","Rheumatoid Arthritis-Associated Interstitial Lung Disease","Scleroderma-Associated Interstitial Lung Disease (SSC-ILD)",[25,26,27,28,19,29,30,31,32,33,34,35,22,36],"COPD","Chronic Obstructive Pulmonary Disease","Lung disease","Emphysema","Healthy Smoker","Smoker","Non-smoker","IPF","RA-ILD","SSC-ILD","Idiopathic Pulmonary Fibrosis","Scleroderma-Associated Interstitial Lung Disease","OBSERVATIONAL",null,[],{"count":41,"type":42},2000,"ESTIMATED",[],[45],{"measure":46,"description":47,"timeFrame":48},"Establishing normal ranges for various parameters","The primary objective of the study is to obtain biologic materials from the blood, airways and\u002For urine of normal individuals and individuals with lung disease. The normal are used to establish a set of normal ranges for various parameters. These provide control information when compared to individuals with various pulmonary diseases, and will help in understanding the etiology and pathogenesis of various lung diseases.","Participants upon completing the study will be followed up by a phone call seven days after their visit.",[50],{"measure":51,"description":52,"timeFrame":48},"Learning about the genetic composition of the airway cells","The secondary objective is to learn more about the genetic composition the cells that line the airways (windpipes) of the lungs in normal individuals and in individuals with lung disease.","ALL","18 Years",{"inclusion":56,"exclusion":66,"raw_text":77},[57,58,59,60,61,62,59,60,63,64,60,63,65],"All study subjects should be able to provide informed consent","Males or females ages 18 years and older","Must provide HIV informed consent","Must provide informed consent","Males and females age 18 years and older","Lung disease proven by at least one of the following: symptoms consistent with pulmonary disease; (2) chest X-rays consistent with lung disease; (3) pulmonary function tests consistent with lung disease; (4) lung biopsy consistent with lung disease; (5) family history of lung disease; and\u002For (6) diseases of organs with known association with lung disease","Males and females, age 18 years and older","Lung disease proven by at least one of the following: (1) symptoms consistent with pulmonary disease; (2) chest X-rays consistent with lung disease; (3) pulmonary function tests consistent with lung disease; (4) lung biopsy consistent with lung disease; (5) family history of lung disease; (6) diseases of organs with known association with lung disease, and (7) individuals with the blood eosinophil levels of 5% or greater.","Lung disease proven by at least one of the following: symptoms consistent with pulmonary disease; (2) chest X-rays consistent with lung disease; (3) pulmonary function tests consistent with lung disease; (4) lung biopsy consistent with lung disease; (5) family history of lung disease; and (6) diseases of organs with known association with lung disease",[67,68,69,70,71,72,73,74,75,76,76],"Individuals not deemed in good overall health by the investigator during screening visits and\u002For prior to the bronchoscopy will not be accepted into the study.","Individuals with history of chronic lung disease, including asthma or with recurrent or recent (within three months) acute pulmonary disease will not be accepted into the study.","Individuals with allergies to atropine or any local anesthetic will not be accepted into the study.","Individuals with allergies to pilocarpine, isoproterenol, terbutaline, atropine or aminophylline will not be accepted into the study.","Females who are pregnant or nursing will not be accepted into the study","Any history of allergies to xylocaine, lidocaine, versed, valium, atropine, pilocarpine, isoproterenol, terbutaline, aminophylline, or any local anesthetic will not be included in the study","Individuals deemed unable to complete the bronchoscopy due to health concerns by the investigator.","Females who are pregnant or nursing","Experienced a recent (≤ 8 weeks) pulmonary exacerbation of their disease","Patient refuses consent","Inclusion Criteria:\n\nGroup 1.1 - HEALTHY VOLUNTEER RESEARCH SUBJECTS (Healthy as defined by those not having lung disease and inclusive of: all races, ethnicities, sex, HIV status, smoking status and multiple birth status, etc., within the general population. Smoking status is defined for individuals that may use any of the following: cigarettes, pipes, E-cigarettes, waterpipe, shisha, etc.):\n\n* All study subjects should be able to provide informed consent\n* Males or females ages 18 years and older\n* Must provide HIV informed consent\n\nGroup 1.2 - VOLUNTEER RESEARCH SUBJECTS WITH LUNG DISEASE (As defined by those having lung disease or symptoms of lung disease and inclusive of: all races, ethnicities, sex, HIV status, smoking status and multiple birth status, etc., within the general population. Smoking status is defined for individuals that may use any of the following: cigarettes, pipes, E-cigarettes, waterpipe, shisha, etc.):\n\n* Must provide informed consent\n* Males and females age 18 years and older\n* Lung disease proven by at least one of the following: symptoms consistent with pulmonary disease; (2) chest X-rays consistent with lung disease; (3) pulmonary function tests consistent with lung disease; (4) lung biopsy consistent with lung disease; (5) family history of lung disease; and\u002For (6) diseases of organs with known association with lung disease\n* Must provide HIV informed consent\n\nAdditional Inclusion criteria for CF subjects:\n\n• All CF subjects will be homozygous for the ΔF508 mutation, with mild-moderate lung disease as defined by FEV1 ≥ 50%\n\nGroup 2 - WCMC\u002FNYPH CLINICAL PATIENTS\n\n* Must provide informed consent\n* Males and females, age 18 years and older\n* Lung disease proven by at least one of the following: (1) symptoms consistent with pulmonary disease; (2) chest X-rays consistent with lung disease; (3) pulmonary function tests consistent with lung disease; (4) lung biopsy consistent with lung disease; (5) family history of lung disease; (6) diseases of organs with known association with lung disease, and (7) individuals with the blood eosinophil levels of 5% or greater.\n\nGroup 3 - PCNY CLINICAL PATIENTS VOLUNTEER RESEARCH SUBJECTS WITH LUNG DISEASE\n\n* Must provide informed consent\n* Males and females, age 18 years and older\n* Lung disease proven by at least one of the following: symptoms consistent with pulmonary disease; (2) chest X-rays consistent with lung disease; (3) pulmonary function tests consistent with lung disease; (4) lung biopsy consistent with lung disease; (5) family history of lung disease; and (6) diseases of organs with known association with lung disease\n\nExclusion Criteria:\n\nGroup 1.1 - HEALTHY VOLUNTEER RESEARCH SUBJECTS\n\n* Individuals not deemed in good overall health by the investigator during screening visits and\u002For prior to the bronchoscopy will not be accepted into the study.\n* Individuals with history of chronic lung disease, including asthma or with recurrent or recent (within three months) acute pulmonary disease will not be accepted into the study.\n* Individuals with allergies to atropine or any local anesthetic will not be accepted into the study.\n* Individuals with allergies to pilocarpine, isoproterenol, terbutaline, atropine or aminophylline will not be accepted into the study.\n* Females who are pregnant or nursing will not be accepted into the study\n\nGroup 1.2 - VOLUNTEER RESEARCH SUBJECTS WITH LUNG DISEASE\n\n* Any history of allergies to xylocaine, lidocaine, versed, valium, atropine, pilocarpine, isoproterenol, terbutaline, aminophylline, or any local anesthetic will not be included in the study\n* Individuals deemed unable to complete the bronchoscopy due to health concerns by the investigator.\n* Females who are pregnant or nursing\n\nAdditional Exclusion criteria for CF subjects:\n\n* Experienced a recent (≤ 8 weeks) pulmonary exacerbation of their disease\n\nGroup 2 - WCMC\u002FNYPH CLINICAL PATIENTS\n\n* Patient refuses consent\n\nGroup 3 - PCNY CLINICAL PATIENTS\n\n* Patient refuses consent",[79,80],"ADULT","OLDER_ADULT",[82],{"facility":83,"status":7,"city":84,"state":84,"zip":85,"country":86,"contacts":87,"geoPoint":93},"Weill Cornell Medical College and Weill Cornell Medical Center, Department of Genetic Medicine","New York","10065-4870","United States",[88],{"name":89,"role":90,"phone":91,"email":92},"Niamh Savage","CONTACT","212-746-0284","nis2049@med.cornell.edu",{"lat":94,"lon":95},40.71427,-74.00597,[97],{"name":89,"role":90,"phone":98,"email":92},"12127460284",[100],{"name":101,"affiliation":12,"role":102},"Ronald G. Crystal, M.D.","PRINCIPAL_INVESTIGATOR",[104,108],{"pmid":105,"type":106,"citation":107},"29754582","DERIVED","Staudt MR, Salit J, Kaner RJ, Hollmann C, Crystal RG. Altered lung biology of healthy never smokers following acute inhalation of E-cigarettes. Respir Res. 2018 May 14;19(1):78. doi: 10.1186\u002Fs12931-018-0778-z.",{"pmid":109,"type":106,"citation":110},"27462120","Strulovici-Barel Y, Staudt MR, Krause A, Gordon C, Tilley AE, Harvey BG, Kaner RJ, Hollmann C, Mezey JG, Bitter H, Pillai SG, Hilton H, Wolff G, Stevenson CS, Visvanathan S, Fine JS, Crystal RG. Persistence of circulating endothelial microparticles in COPD despite smoking cessation. Thorax. 2016 Dec;71(12):1137-1144. doi: 10.1136\u002Fthoraxjnl-2015-208274. Epub 2016 Jul 26.",[],{"nct_id":4,"conditions":113,"biomarkers":115},[26,114,35,22,36],"Cystic Fibrosis",[116],"CFTR Gene",{"nct_id":4,"found":14,"summary":118,"prompt_version":128},{"design":119,"status":120,"heading":121,"summary":122,"follow_up":123,"word_count":124,"commitments":125,"compensation":126,"drugs_mentioned":127},"This is an observational study with a planned enrollment of 2000 participants. It is not a drug trial, but rather focuses on collecting biological samples.","completed","Collection of Airway, Blood, and Urine Specimens for Lung Disease Research","This observational study aims to collect samples of blood, urine, and airway (breathing tube) cells from people with lung diseases like Chronic Obstructive Pulmonary Disease (COPD), Idiopathic Pulmonary Fibrosis (IPF), and Rheumatoid Arthritis-Associated Interstitial Lung Disease, as well as from healthy volunteers. The goal is to understand the causes and progression of lung diseases by comparing samples from healthy individuals to those with lung conditions. Researchers will look at genetic information and other factors in these samples. Healthy volunteers help establish what is considered \"normal\" so that changes seen in people with lung disease can be better understood. This study is currently looking for participants.","Participants will receive a phone call seven days after their visit.",105,"You would provide blood, urine, and\u002For airway samples. Airway samples may be collected using a bronchoscope (a thin tube inserted into the lungs).","Not stated in the trial record.",[],"v2"]