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Stromal Gene Expression During Pulmonary Sarcoidosis

This study has suspended participant recruitment.
(Interim analysis)
Sponsor:
Information provided by:
Ohio State University
ClinicalTrials.gov Identifier:
NCT00837668
First received: February 4, 2009
Last updated: July 21, 2010
Last verified: July 2010
History of Changes
  Purpose

to determine the genetic pathways operating at the tissue level to cause granulomatous inflammation in the lungs and lymph nodes of patients with sarcoidosis. By so doing, we hope to identify unique genetic mechanisms which will aid in the diagnosis of sarcoidosis and will help us understand the pathogenesis of this poorly understood disease.


Condition
Sarcoidosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Stromal Gene Expression During Pulmonary Sarcoidosis

Resource links provided by NLM:

MedlinePlus related topics: Sarcoidosis
U.S. FDA Resources

Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • To Identify Gene Expression Patterns That Specifically Correlate With Active Pulmonary Sarcoidosis. [ Time Frame: end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To Determine if Gene Expression Patterns Correlate With The Severity of Illness Of Sarcoidosis Patients [ Time Frame: end of study ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

lung tissue


Estimated Enrollment: 110
Study Start Date: April 2005
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
sarcoidosis
sarcoidosis patients undergoing clinical bronchoscopy

Detailed Description:

to collect small sample of lung tissue recovered from a clinical procedure such as bronchoscopy, or a mediastinoscopy (a procedure in which a lighted instrument (mediastinoscope) is inserted through a neck incision to visually examine the structures in the top of the chest cavity and to take a sample (biopsy) of tissue.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients from sarcoidosis clinic

Criteria

Inclusion Criteria:

  • diagnosis of sarcoidosis

Exclusion Criteria:

  • inability to provide consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00837668

Locations
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Elliott Crouser, MD Ohio State University
  More Information

No publications provided

Responsible Party: Elliott Crouser, The Ohio State University
ClinicalTrials.gov Identifier: NCT00837668     History of Changes
Other Study ID Numbers: 2005H0018
Study First Received: February 4, 2009
Last Updated: July 21, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
sarcoidosis
stromal gene expression
pulmonary sarcoidosis
bronchoscopy

Additional relevant MeSH terms:
Sarcoidosis
Sarcoidosis, Pulmonary
Lymphoproliferative Disorders
Lymphatic Diseases
 Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013