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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL107882-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Boehringer Ingelheim | INDUSTRY |
| Cystic Fibrosis Foundation | OTHER |
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The purpose of this study is to obtain biologic materials from the blood, airways and/or 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/or 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/or 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/or 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/or 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1.1 HEALTHY 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. | ||
| 1.2 SUBJECTS WITH LUNG DISEASE | 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) | ||
| 2. WCMC/NYPH CLINICAL PATIENTS | Subjects may be recruited if subjects fit inclusion/exclusion criteria and are deemed eligible to participate as long as informed consent is given. Sample collection will occur during a separate study visit. WCMC/NYPH clinical patients will not undergo any additional procedures listed in this protocol as part of this research study. | ||
| 3. PCNY CLINICAL PATIENTS | Subjects may be recruited if subjects fit inclusion/exclusion criteria and are deemed eligible to participate as long as informed consent is given. Sample collection will occur during a separate study visit. Clinical patients seen at the Pulmonary Consultants of New York will only undergo the nasal sample collection and may be asked to have a blood draw of about 2 teaspoons (9ml). |
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| Measure | Description | Time Frame |
|---|---|---|
| Establishing normal ranges for various parameters | The primary objective of the study is to obtain biologic materials from the blood, airways and/or 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Participants upon completing the study will be followed up by a phone call seven days after their visit. |
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Inclusion Criteria:
Group 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.):
Group 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.):
Additional Inclusion criteria for CF subjects:
• All CF subjects will be homozygous for the ΔF508 mutation, with mild-moderate lung disease as defined by FEV1 ≥ 50%
Group 2 - WCMC/NYPH CLINICAL PATIENTS
Group 3 - PCNY CLINICAL PATIENTS VOLUNTEER RESEARCH SUBJECTS WITH LUNG DISEASE
Exclusion Criteria:
Group 1.1 - HEALTHY VOLUNTEER RESEARCH SUBJECTS
Group 1.2 - VOLUNTEER RESEARCH SUBJECTS WITH LUNG DISEASE
Additional Exclusion criteria for CF subjects:
Group 2 - WCMC/NYPH CLINICAL PATIENTS
Group 3 - PCNY CLINICAL PATIENTS
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New York Metropolitan area residents
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Niamh Savage | Contact | 12127460284 | nis2049@med.cornell.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ronald G. Crystal, M.D. | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medical College and Weill Cornell Medical Center, Department of Genetic Medicine | Recruiting | New York | New York | 10065-4870 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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/s12931-018-0778-z. | |
| 27462120 | Derived | 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/thoraxjnl-2015-208274. Epub 2016 Jul 26. |
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Specimens collected may include blood, urine and airway samples (nasal, airway brushing, biopsy and/or washings) from consenting subjects. Subjects will include both individuals diagnosed with lung disease and healthy control subjects.
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| D054990 | Idiopathic Pulmonary Fibrosis |
| D008171 | Lung Diseases |
| D004646 | Emphysema |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D015438 | Health Behavior |
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
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