[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100504917":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":28,"locations":38,"responsibleParty":56,"collaborators":58,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":86,"sex":92,"minAge":93,"maxAge":10,"enrollmentInfo":94,"targetDuration":10,"studyType":97,"phases":10,"briefSummary":98,"conditions":99,"keywords":10,"overallStatus":40,"whyStopped":10,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Albert Einstein College of Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Bronchoscopy subjects, current or former smokers",null,"Bronchoscopy subjects \\>=21 yo, current or former smokers",[13],"Other: Observational only, all subjects; measure DNA mutation and proteomic survey.",{"label":15,"type":10,"description":16,"interventionNames":17},"Bronchoscopy subjects, never smokers","Bronchoscopy subjects \\>=21 yo, never smokers",[13],[19],{"type":6,"name":20,"description":20,"armGroupLabels":21,"otherNames":22},"Observational only, all subjects; measure DNA mutation and proteomic survey.",[9,15],[23],"Observational study to develop a cough diagnostic",[25],{"name":26,"affiliation":5,"role":27},"Simon D Spivack, MD","PRINCIPAL_INVESTIGATOR",[29,34],{"name":30,"role":31,"phone":32,"phoneExt":10,"email":33},"Aham Okorozo, MD","CONTACT","718-678-1035","ahamefule.okorozo@einsteinmed.edu",{"name":35,"role":31,"phone":36,"phoneExt":10,"email":37},"Khulan Batbayar, PhD","718-678-1040","Khulan.Batbayar@einsteinmed.edu",[39],{"facility":5,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","The Bronx","New York","10461","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-73.86641,40.84985,{"lat":50,"lon":49},[53,55],{"name":26,"role":31,"phone":36,"phoneExt":10,"email":54},"simon.spivack@einsteinmed.edu",{"name":30,"role":31,"phone":32,"phoneExt":10,"email":33},{"type":57,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[59,62,64,66,68,71,74,76,78,80,82],{"name":60,"class":61},"National Center for Advancing Translational Sciences (NCATS)","NIH",{"name":63,"class":61},"National Cancer Institute (NCI)",{"name":65,"class":61},"National Heart, Lung, and Blood Institute (NHLBI)",{"name":67,"class":61},"National Institute of Environmental Health Sciences (NIEHS)",{"name":69,"class":70},"Evaluate Diagnostics","UNKNOWN",{"name":72,"class":73},"James J. Peters Veterans Affairs Medical Center","FED",{"name":75,"class":6},"Touro University",{"name":77,"class":6},"Hackensack Meridian Health",{"name":79,"class":6},"The Scripps Research Institute",{"name":81,"class":6},"Weill Medical College of Cornell University",{"name":83,"class":6},"Cold Spring Harbor Laboratory","100504917","cough-capture-as-a-portal-into-the-lung-100504917",false,"NCT05854563","Cough Capture as a Portal Into the Lung","Genetics of Lung Disease (Exhaled Breath DNA Methylation in Lung Carcinogenesis)","CC1","Inclusion Criteria:\n\n* Age: minimum age of 21 years\n* Gender: Male and Female adults\n* Ethnicity: All ethnic groups and races\n* Subjects undergoing bronchoscopy for diagnostic purposes or therapy\n* Subjects without a known diagnosis of lung cancer who are not scheduled for lung tissue collection procedures\n* Subjects with a known or suspected diagnosis of asthma or COPD and are scheduled for a visit at Montefiore Asthma or COPD Center and individual practices, and\u002For in-hospital with exacerbation\n\nExclusion Criteria:\n\n* Bleeding diathesis or known coagulopathy precluding clinically indicated biopsy (e.g., INR\\>1.3, PTTr\\>1.3), thrombocytopenia \\\u003C50,000, uremia with serum creatinine \\>3.0\n* Unstable angina\n* Recent myocardial infarction (within 3 months),\n* Uncontrolled congestive heart failure or severe pulmonary hypertension (mean PAP\\>75 mmHg)","ALL","21 Years",{"count":95,"type":96},2000,"ESTIMATED","OBSERVATIONAL","The lung is a privileged organ; blood does not reflect most lung processes well, if at all. Therefore, for population scale diagnostics, the investigator team is developing non-invasive portals to the lung, for eventual early detection\u002Frisk assessment and diagnostic purposes. However, large macromolecules are not likely suspended nor readily detected in the breath. In particular, genomic DNA in the breath condensate (EBC) is very sparse, and where present, generally highly fragmented, not readily amenable to sequencing based assessments of DNA somatic mutation burden or distribution. Because gDNA (and protein) is challenging to obtain non-invasively from EBC, the study team considered alternative surrogate lower airway specimens. Cough capture is rarely done, and the investigator team is in the process of optimizing its collection. Importantly, the team will be evaluating how much of coughed material is from saliva contamination. Additionally, analyzing material that is target captured by capturing deep lung extracellular vesicles (EVs) using immobilized CCSP\u002FSFTPC antibodies targeting EVs from distal bronchiole Club and alveolar type 2 cells could circumvent the mouth contamination problem, leaving a non-invasive portal to the deep lung suitable for large molecules, and in turn suitable for myriad epidemiologic and clinical applications.\n\nThe investigator team proposes (Aim 1) to pursue optimizing cough collection, and testing the efficacy and practicality of partitioning cough specimen for deep-lung specific extra-cellular vesicles (EVs). This cough specimen will be compared to that from invasively collected deep lung samples BAL\u002Fbronchial brushings, and to the potential contaminating mouth rinse, all from the same individuals. (Aim 2) The study team initially proposes to examine these cough specimens for somatic mutations by SMM bulk sequencing for single nucleotide variation, developed in the Vijg\u002FMaslov labs. Finally, the investigator team will (Aim 3) test all airway specimens (cough, mouthwash and BAL) for lung surrogacy of cough, using proteins known to be specific for lung, as opposed to oral cavity\u002Fsaliva, in the Sidoli\u002Fproteomics core.\n\nThe investigator team envisions that the translational impact of non-invasively obtained DNA or protein markers could allow for more rapid acute clinical diagnoses, and facilitate precision prevention and\u002For early detection of many acute and chronic respiratory disorders, including lung cancer, asthma and COPD, acute and chronic infectious diseases, and indeed systemic disorders of inflammation and metabolism.",[100,101,102,103,104],"Lung Diseases","Lung Cancer","Lung Diseases, Obstructive","Lung Diseases, Interstitial","Lung Inflammation","2026-01-12",{"date":107,"type":108},"2026-01-13","ACTUAL",{"date":110,"type":108},"2023-03-28",{"date":112,"type":96},"2027-06",{"name":5,"class":6},1]