Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies

• ClinicalTrials.gov Identifier: NCT01776398
• Recruitment Status: Recruiting
• First Posted: January 28, 2013
• Last Update Posted: March 28, 2019
• Sponsor: Weill Medical College of Cornell University
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): Weill Medical College of Cornell University

Study Description

Brief Summary:

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.

Condition or disease
Chronic Obstructive Pulmonary Disease (COPD); Smoking; Smoking Cessation; Idiopathic Pulmonary Fibrosis (IPF); Rheumatoid Arthritis-Associated Interstitial Lung Disease (RA-ILD); Scleroderma-Associated Interstitial Lung Disease (SSC-ILD)

Detailed Description:

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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 2000 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies
• Actual Study Start Date: July 16, 2012
• Estimated Primary Completion Date: July 2020
• Estimated Study Completion Date: July 2020

Groups and Cohorts

Group/Cohort
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).

Outcome Measures

Primary Outcome Measures :

1. Establishing normal ranges for various parameters [ Time Frame: Participants upon completing the study will be followed up by a phone call seven days after their visit. ]
   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.

Secondary Outcome Measures :

1. Learning about the genetic composition of the airway cells [ Time Frame: Participants upon completing the study will be followed up by a phone call seven days after their visit. ]
   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.

Biospecimen Retention:   Samples With DNA

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

New York Metropolitan area residents

Criteria

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.):

• All study subjects should be able to provide informed consent
• Males or females ages 18 years and older
• Must provide HIV informed consent

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.):

• 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/or (6) diseases of organs with known association with lung disease
• Must provide HIV informed consent

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

• Must provide informed consent
• 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; and (6) diseases of organs with known association with lung disease

Group 3 - PCNY CLINICAL PATIENTS VOLUNTEER RESEARCH SUBJECTS WITH LUNG DISEASE

• 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 (6) diseases of organs with known association with lung disease

Exclusion Criteria:

Group 1.1 - HEALTHY VOLUNTEER RESEARCH SUBJECTS

• Individuals not deemed in good overall health by the investigator during screening visits and/or 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

Group 1.2 - VOLUNTEER RESEARCH SUBJECTS WITH LUNG DISEASE

• 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

Additional Exclusion criteria for CF subjects:

• Experienced a recent (≤ 8 weeks) pulmonary exacerbation of their disease

Group 2 - WCMC/NYPH CLINICAL PATIENTS

• Patient refuses consent

Group 3 - PCNY CLINICAL PATIENTS

• Patient refuses consent

Contacts and Locations

Contacts

Contact: Grace Mammen, BA, CCRP; 6469622672; gwm2004@med.cornell.edu

Locations

United States, New York

Weill Cornell Medical College and Weill Cornell Medical Center, Department of Genetic Medicine; Recruiting

New York, New York, United States, 10065-4870

Contact: Grace Mammen, BA, CCRP 646-962-2672 gwm2004@med.cornell.edu

Sub-Investigator: Ben-Gary Harvey, M.D.

Sub-Investigator: Robert Kaner, M.D.

Sub-Investigator: Daniel Libby, M.D.

Sub-Investigator: Brian Gelbman, M.D.

Sub-Investigator: Sarah O'Beirne, M.D.

Sub-Investigator: Odelya Pagovich, M.D.

Sponsors and Collaborators

Weill Medical College of Cornell University

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Ronald G. Crystal, M.D.; Weill Medical College of Cornell University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT01776398 History of Changes
• Other Study ID Numbers: 1204012331; 1R01HL107882-01 ( U.S. NIH Grant/Contract )
• First Posted: January 28, 2013
• Last Update Posted: March 28, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by Weill Medical College of Cornell University:

COPD; Chronic Obstructive Pulmonary Disease; Lung disease; Emphysema; Smoking; Healthy Smoker; Smoker; Non-smoker; IPF; RA-ILD; SSC-ILD; Idiopathic Pulmonary Fibrosis; Rheumatoid Arthritis-Associated Interstitial Lung Disease; Scleroderma-Associated Interstitial Lung Disease

Additional relevant MeSH terms:

Arthritis; Arthritis, Rheumatoid; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Idiopathic Interstitial Pneumonias; Lung Diseases, Interstitial; Scleroderma, Systemic; Scleroderma, Diffuse; Fibrosis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Respiratory Tract Diseases; Skin Diseases