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

Launched by WEILL MEDICAL COLLEGE OF CORNELL UNIVERSITY · Jan 22, 2013

Keywords

ClinConnect Summary

This clinical trial is studying how to better understand lung diseases such as Chronic Obstructive Pulmonary Disease (COPD), Idiopathic Pulmonary Fibrosis (IPF), and others by collecting samples from the blood, airways, and urine of both healthy individuals and those with lung conditions. The goal is to compare these samples to establish what is considered normal and to learn more about how lung diseases develop. This can help researchers find out why these diseases occur and how they change the body.

To participate, you must be at least 18 years old and provide written consent. Healthy volunteers should not have any lung diseases, while those with lung conditions must have proof of their diagnosis through medical tests or symptoms. Participants can expect to undergo some tests and provide biological samples, which will help advance research in this important area. It’s worth noting that individuals with certain health issues or allergies may not be eligible for the study, and pregnant or nursing women are also excluded for safety reasons.

Gender

ALL

Eligibility 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