Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01776398|
Recruitment Status : Suspended (Per IRB COVID-19 guidance on conducting human subjects research.)
First Posted : January 28, 2013
Last Update Posted : March 31, 2020
|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)|
|Study Type :||Observational|
|Estimated Enrollment :||2000 participants|
|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 :||January 2025|
|Estimated Study Completion Date :||January 2026|
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).
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01776398
|United States, New York|
|Weill Cornell Medical College and Weill Cornell Medical Center, Department of Genetic Medicine|
|New York, New York, United States, 10065-4870|
|Principal Investigator:||Ronald G. Crystal, M.D.||Weill Medical College of Cornell University|