Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies
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Purpose
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.
| Condition |
|---|
|
Chronic Obstructive Pulmonary Disease (COPD) Asthma Smoking Smoking Cessation Healthy Smoker |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies |
- 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. ] [ Designated as safety issue: No ]The primary endpoint 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.
Biospecimen Retention: Samples With DNA
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.
| Estimated Enrollment: | 2000 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | December 2017 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| 1.1 HEALTHY VOLUNTEER RESEARCH SUBJECTS |
| 1.2 VOLUNTEER RESEARCH SUBJECTS WITH LUNG DISEASE |
| 2. WCMC/NYPH CLINICAL PATIENTS |
| 3. PCNY CLINICAL PATIENTS |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
New York Metropolitan area residents
Inclusion Criteria:
Group 1.1
- 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
- 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
Group 2
- 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
- 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
- Individuals not deemed in good overall health by the investigator will not be accepted into the study.
- Habitual use of drugs and/or alcohol within the past six months (Acceptable: Marijuana one time in three months; average of two alcoholic beverages per day; drug and/or alcohol abuse is defined as per the DSM-IV Substance Abuse Criteria).
- 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
- 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
- Habitual use of drugs and/or alcohol within the past six months (Acceptable: Marijuana one time in three months; average of two alcoholic beverages per day; drug and/or alcohol abuse is defined as per the DSM-IV Substance Abuse Criteria)
- Females who are pregnant or nursing
Group 2
- Patient refuses consent
Group 3
- Patient refuses consent
Contacts and Locations| Contact: Sharon Radisch, MS | 646-962-2672 | shr2016@med.cornell.edu |
| Contact: Ramon Sosa, BA | 646-962-2672 | ras2045@med.cornell.edu |
| 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 | |
| Sub-Investigator: Ben-Gary Harvey, M.D. | |
| Sub-Investigator: Ann Tilley, M.D. | |
| Sub-Investigator: Robert Kaner, M.D. | |
| Sub-Investigator: Daniel Libby, M.D. | |
| Sub-Investigator: Brian Gelbman, M.D. | |
| Sub-Investigator: Sharon Radisch, M.S | |
| Sub-Investigator: Jenny Yee-Levin, P.A. | |
| Sub-Investigator: Ramon Sosa, BA | |
| Sub-Investigator: Malesa Pereira, BA | |
| Sub-Investigator: Dorothy Ryan, M.D. | |
| Sub-Investigator: Ida Cao, BA | |
| Principal Investigator: | Ronald G. Crystal, M.D. | Weill Medical College of Cornell University |
More Information
No publications provided
| Responsible Party: | Weill Medical College of Cornell University |
| ClinicalTrials.gov Identifier: | NCT01776398 History of Changes |
| Other Study ID Numbers: | 1204012331, 1R01HL107882-01 |
| Study First Received: | October 10, 2012 |
| Last Updated: | January 22, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Weill Medical College of Cornell University:
|
COPD Chronic Obstructive Pulmonary Disease Lung disease Emphysema Smoking |
Smoking Cessation Quit Smoking Healthy Smoker Smoker Non-smoker |
Additional relevant MeSH terms:
|
Asthma Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Smoking Lung Diseases, Obstructive Bronchial Diseases |
Respiratory Tract Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Habits |
ClinicalTrials.gov processed this record on May 16, 2013