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

NCT01776398 | Recruiting DMC

• 2 other identifiers: 12040123311R01HL107882-01
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Learning about the genetic composition of the airway cells

  Participants upon completing the study will be followed up by a phone call seven days after their visit.

Study Arms (4)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

New York Metropolitan area residents

You may qualify if:

• 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
• 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; (6) diseases of organs with known association with lung disease, and (7) individuals with the blood eosinophil levels of 5% or greater.
• Group 3 - PCNY CLINICAL PATIENTS VOLUNTEER RESEARCH SUBJECTS WITH LUNG DISEASE

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Boehringer Ingelheim: collaborator
• Cystic Fibrosis Foundation: collaborator

Study Sites (1)

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

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

RECRUITING

Related Publications (2)

• 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.

  PMID: 29754582 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.

  PMID: 27462120 DERIVED

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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Smoking; Smoking Cessation; Idiopathic Pulmonary Fibrosis; Lung Diseases; Emphysema

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Health Behavior; Pulmonary Fibrosis; Lung Diseases, Interstitial

Study Officials

• Ronald G. Crystal, M.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Niamh Savage

CONTACT

12127460284; nis2049@med.cornell.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2012
• First Posted: January 28, 2013
• Study Start: August 29, 2012
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 14, 2025

Record last verified: 2025-11

Locations

US (1)