Genomic Research in Sarcoidosis

Completed

Conditions studied: Sarcoidosis

In brief

This project is designed to address the following hypothesis: Distinct patterns in lung microbiome are characteristic of sarcoidosis phenotypes and reflected in changes in systemic inflammatory responses as measured by peripheral changes in gene transcription. The Specific Aims are: 1. To identify peripheral blood mononuclear cell (PBMC) gene expression patterns that characterize distinct sarcoidosis phenotypes. 2. To determine whether patterns in the lung microbiome are associated with sarcoidosis severity and disease phenotypes 3. To correlate mRNA and microRNA expression patterns in sarcoidosis affected organs with changes in microbiome, clinical parameters and PBMC gene expression patterns 4. To integrate clinical, transcriptomic, and microbiome data to identify novel molecular phenotypes in sarcoidosis.

Key facts

Study ID

NCT01831739

Run by

University of Pittsburgh

People needed

368

Starts

2013-05-01

Expected to finish

2015-09-01

Last updated by the study team

2016-01-12

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age between the ages of 18 and 85.
• Have a diagnosis of sarcoidosis established by consensus criteria (ATS/ERS), confirmed by either biopsy or by manifestations consistent with acute sarcoidosis (Löfgren's syndrome) in absence of other known diagnosis.
• OR Have a suspected diagnosis of sarcoidosis and is scheduled to undergo a biopsy procedure to confirm a diagnosis of sarcoidosis using the same consensus criteria (ATS/ERS).
• Able to tolerate and willing to undergo study procedures.
• Be capable of understanding study forms.
• Provide signed informed consent.

You may not qualify if…

• History of comorbid condition severe enough to significantly increase risks based on investigator discretion.
• Currently an active smoker.
• Undergoing bronchoscopy (clinical or research) with any one of the following:
• severe pulmonary impairment (<50% predicted FVC, <1 L FEV1; DLco <40% predicted, resting hypoxemia <92% with or without supplemental oxygen)
• other co-morbid disease that would preclude bronchoscopy.
• hypersensitivity to or intolerance of any of the drugs required for sedation during conscious sedation bronchoscopy.
• Known systemic autoimmune disease such as rheumatoid arthritis, lupus, scleroderma, Sjögrens, etc.
• Found to have an alternative interstitial lung disease during evaluation and/or screening.
• Diagnosis of unstable cardiovascular disease including myocardial infarction in the past 6 weeks, uncontrolled congestive heart failure, or uncontrolled arrhythmia
• Use of anticoagulation (patients on warfarin or clopidogrel will be excluded, patients on aspirin alone can be studied even with concurrent use)
• Dementia or other cognitive dysfunction which in the opinion of the investigator would prevent the participant from consenting to the study or completing study procedures
• Non-Sarcoidosis pulmonary disease (e.g., rheumatoid arthritis, lupus, scleroderma) that, in the opinion of the investigator, limits the interpretability of the analysis of sarcoidosis pulmonary disease
• Primary biliary cirrhosis or autoimmune hepatitis
• Crohn's disease
• Chronic beryllium disease
• Have an active bacterial or viral infection at time of screening.
• Have an active or ongoing serious infection, including HIV, HBV and HCV
• Active tuberculosis or are taking any medication for tuberculosis
• Have a history of demyelinating diseases, lymphoproliferative diseases, or other malignancies other than presumed cured non-metastatic skin cancer
• Have evidence of a likely malignancy on chest x-ray
• Are currently pregnant at time of screening
• Currently institutionalized (e.g., prisons, long-term care facilities)
• Hypersensitivity to or intolerance of albuterol sulfate or propellants or excipients of the inhalers
• History of Lung volume reduction surgery, lung resection or bronchoscopic lung volume reduction in any form.
• History of lung or other organ transplant

Where it is running

• Arizona Health Sciences Center — Tucson, Arizona, United States
• University of California - San Francisco — San Francisco, California, United States
• National Jewish Health — Denver, Colorado, United States
• Yale University — New Haven, Connecticut, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Medical University of South Caolina — Charleston, South Carolina, United States
• Vanderbilt University — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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