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Immunological Characterization of Bronchoalveolar Cells in Normals

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00843414
First Posted: February 13, 2009
Last Update Posted: July 7, 2016
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.
Information provided by (Responsible Party):
Mark D. Wewers, MD, Ohio State University
  Purpose
To obtain the monocytes (white blood cells) from normal volunteers for the purpose of studying how proteins, fats, carbohydrates, as well as RNA and DNA for gene expression, relate to immunity. This information will be compared to other studies in patients with lung diseases such as Emphysema, Sarcoidosis, and Interstitial Pulmonary Fibrosis.

Condition
Lung Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Immunological Characterization of Bronchoalveolar Cells in Normals

Resource links provided by NLM:


Further study details as provided by Mark D. Wewers, MD, Ohio State University:

Primary Outcome Measures:
  • comparing the specific immune function (e.g. ability to sense endotoxin and release a cytokine) from blood monocytes as compared to human alveolar macrophages [ Time Frame: end of study ]

Secondary Outcome Measures:
  • Analysis of lung proteins present in BAL fluid [ Time Frame: end of study ]

Biospecimen Retention:   Samples With DNA
blood lung fluid (BAL)

Enrollment: 1232
Study Start Date: March 1978
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Detailed Description:
To determine the functional capabilities of cells obtained from bronchoalveolar lavage fluid and peripheral blood monocytes from normal individuals. The ongoing objective varies from investigation to investigation but in general the investigational goals are to better understand the immune function of monocytes purified from normal volunteers. In some instances the emphasis will be upon comparing the specific immune function (e.g. ability to sense endotoxin and release a cytokine) from blood monocytes as compared to human alveolar macrophages. This comparison is not the only goal of the study, however. In many cases the immune function of the monocyte will be sufficient in and of itself as an investigational goal. In other cases the same is true of alveolar macrophage function.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
community sample
Criteria

Inclusion Criteria:

  • healthy

Exclusion Criteria:

  • unable to consent
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00843414


Locations
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43026
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Mark D Wewers, MD Ohio State University
  More Information

Responsible Party: Mark D. Wewers, MD, Associate Director of Pulmonary Research, Ohio State University
ClinicalTrials.gov Identifier: NCT00843414     History of Changes
Other Study ID Numbers: 1978H0059
First Submitted: February 12, 2009
First Posted: February 13, 2009
Last Update Posted: July 7, 2016
Last Verified: April 2011

Keywords provided by Mark D. Wewers, MD, Ohio State University:
Emphysema
Sarcoidosis
Interstitial Pulmonary Fibrosis

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases