Collecting biological samples from individuals with and without lung disease
Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies
This study is collecting blood, urine, and airway samples from both healthy people and those with lung diseases to see how their biology differs and learn more about these conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT01776398 on ClinicalTrials.gov |
What this trial studies
This study aims to gather blood, urine, and airway specimens from both healthy individuals and those diagnosed with various lung diseases, including COPD and idiopathic pulmonary fibrosis. The collected samples will be used to analyze genetic expression and other biological markers to better understand the causes and progression of lung diseases. By comparing samples from healthy controls to those with lung conditions, researchers hope to establish normal ranges for various parameters and gain insights into the pathogenesis of these diseases. The study employs techniques such as bronchoscopy to obtain airway cells for further analysis.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older, both healthy volunteers and individuals diagnosed with lung diseases.
Not a fit: Patients who are not able to provide informed consent or are under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to improved understanding and treatment options for patients with lung diseases.
How similar studies have performed: Other studies have successfully utilized similar approaches to investigate lung diseases, suggesting a promising avenue for research.
Eligibility criteria
Show full inclusion / exclusion 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; (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 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
Where this trial is running
New York, New York
- Weill Cornell Medical College and Weill Cornell Medical Center, Department of Genetic Medicine — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Ronald G. Crystal, M.D. — Weill Medical College of Cornell University
- Study coordinator: Niamh Savage
- Email: nis2049@med.cornell.edu
- Phone: 12127460284
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.