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

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
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⁃ 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; (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

• 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

Locations
United States
New York
Weill Cornell Medical College and Weill Cornell Medical Center, Department of Genetic Medicine
RECRUITING
New York
Contact Information
Primary
Niamh Savage
nis2049@med.cornell.edu
12127460284
Time Frame
Start Date: 2012-08-29
Estimated Completion Date: 2028-12
Participants
Target number of participants: 2000
Treatments
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).
Sponsors
Collaborators: Boehringer Ingelheim, Cystic Fibrosis Foundation, National Heart, Lung, and Blood Institute (NHLBI)
Leads: Weill Medical College of Cornell University

This content was sourced from clinicaltrials.gov