[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04896138":3,"trial-entities:NCT04896138":79,"trial-summary:NCT04896138":85},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":25,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":29,"interventions":32,"primary_outcomes":37,"secondary_outcomes":45,"sex":46,"minimum_age":47,"maximum_age":27,"healthy_volunteers":48,"eligibility_criteria":49,"std_ages":56,"locations":59,"central_contacts":69,"overall_officials":70,"references":77,"see_also_links":78},"NCT04896138","20937","University of Virginia Natural History Study","A Study of the Natural Progression of Interstitial Lung Disease","ENROLLING_BY_INVITATION","2035-08-31","2024-05","2024-05-08","2018-08-28","University of Virginia","OTHER",false,"Data and specimens will be collected longitudinally from patients seen in the UVA Interstitial Lung Disease (ILD) clinic in order to describe the phenotypic expression of various interstitial lung diseases. Samples will also be collected from a control group for comparison purposes.\n\nAll data will be entered into a repository for future research purposes or screening for new studies that become available. This data will help identify trends and hopefully lead to a better understanding of the disease progression, treatment options, and outcomes.","Following the clinical course of patients with ILD will allow description of the natural history of these diseases and prospective analysis of the following specific questions:\n\n1. Can surrogate physiological markers of disease progression be used in place of mortality? Mortality of a defined cohort of patients will be developed. The surrogate markers include but are not limited to serial cardiopulmonary exercise testing, pulmonary function testing, 6-minute walk testing, HRCT scanning and echocardiography.\n2. Do alternative assessments such as quality of life (QOL) questionnaires provide early prediction of physiological change as measured by the previously described parameters? Periodic QOL questionnaires are regularly conducted in clinic and will be followed\n3. Does rate of deterioration as measured by these previously described parameters affect response to therapy? If we pre-identify rapid decliners from stable subjects, does this variable affect the response to whatever therapy is applied?\n4. Can genetic analysis, genomics, proteomics, microbial and other biomarkers in the blood and cheeks provide insight into the polymorphisms and other elements related to the etiology and pathology of the lung damage?",[19,20,21,22,23,24],"Interstitial Lung Disease","Idiopathic Pulmonary Fibrosis","Sarcoidosis","Connective Tissue Diseases","Hypersensitivity Pneumonitis","Idiopathic Interstitial Pneumonias",[],"OBSERVATIONAL",null,[],{"count":30,"type":31},2500,"ESTIMATED",[33],{"type":14,"name":19,"description":34,"armGroupLabels":35},"Not applicable - this is not an interventional trial",[36],"ILD Cohort",[38,42],{"measure":39,"description":40,"timeFrame":41},"Clinical Course of Disease","Course of disease in patients with ILD will be reviewed prospectively for the duration of the study","Yearly from date of consent until subject is lost to follow-up or death occurs, whichever comes first, assessed up to 144 months",{"measure":43,"description":44,"timeFrame":41},"Subject deaths","Causes of death in patients with ILD will be reviewed prospectively for the duration of the study",[],"ALL","18 Years",true,{"inclusion":50,"exclusion":53,"raw_text":55},[51,52],"Patient presenting to University of Virginia ILD or Pulmonary clinic","Family members accompanying patients (as control subjects)",[54],"Control subjects cannot have ILD","Inclusion Criteria:\n\n* Patient presenting to University of Virginia ILD or Pulmonary clinic\n* Family members accompanying patients (as control subjects)\n\nExclusion Criteria:\n\n* Control subjects cannot have ILD",[57,58],"ADULT","OLDER_ADULT",[60],{"facility":61,"city":62,"state":63,"zip":64,"country":65,"geoPoint":66},"University of Virginia Health System","Charlottesville","Virginia","22908","United States",{"lat":67,"lon":68},38.02931,-78.47668,[],[71,74],{"name":72,"affiliation":61,"role":73},"Imre Noth, MD","PRINCIPAL_INVESTIGATOR",{"name":75,"affiliation":61,"role":76},"Yousef Althulth, MD","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":80,"biomarkers":84},[81,82,83,20,19,21],"Connective Tissue Disorder","Extrinsic Allergic Alveolitis","Idiopathic Interstitial Pneumonia",[],{"nct_id":4,"found":48,"summary":86,"prompt_version":96},{"design":87,"status":88,"heading":89,"summary":90,"follow_up":91,"word_count":92,"commitments":93,"compensation":94,"drugs_mentioned":95},"This is an observational study with a planned enrollment of 2500 participants. It is not testing any specific intervention.","completed","UVA Natural History Study for Interstitial Lung Diseases","This study at the University of Virginia is observing people with Interstitial Lung Disease (ILD), including Idiopathic Pulmonary Fibrosis (IPF), Sarcoidosis, Connective Tissue Diseases, and Hypersensitivity Pneumonitis. Researchers are collecting information and samples over time to better understand how these diseases progress and how different treatments might affect them. They are also including family members without ILD as a comparison group. The goal is to identify trends that could lead to a better understanding of disease progression, treatment options, and outcomes. This is an observational study, meaning there are no interventions or new treatments being tested. The study is currently enrolling up to 2500 participants.","You would be followed yearly from the date of consent until you are lost to follow-up or death occurs, for up to 144 months (12 years).",105,"Not specified in the trial record.","Not stated in the trial record.",[19],"v2"]