Status:
COMPLETED
Genomic Research in Sarcoidosis
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Sarcoidosis
Eligibility:
All Genders
18-85 years
Brief Summary
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 respo...
Detailed Description
Sarcoidosis is a systemic disease characterized by the formation of granulomatous lesions, especially in the lungs, liver, skin, and lymph nodes, with a heterogeneous set of clinical manifestations an...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- Unable to comprehend consent document and/or questionnaires
- Conditional Exclusions:
- Participants who present with an upper respiratory infection or pulmonary exacerbation, either solely participant-identified or that has been clinically treated, in the last four weeks can be rescreened for the study once the four-week window has closed.
- Participants who present with current use of acute antibiotics or have acute antibiotics within the past four weeks can be rescreened for the study ≥28 days after discontinuing acute antibiotics.
- Female participants who present \<3 months after giving birth will be asked to reschedule their visit until three months have passed since the birth.
- Former smoker who quit \< 3months prior to enrollment
Key Trial Info
Start Date :
May 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
368 Patients enrolled
Trial Details
Trial ID
NCT01831739
Start Date
May 1 2013
End Date
September 1 2015
Last Update
January 12 2016
Active Locations (9)
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1
Arizona Health Sciences Center
Tucson, Arizona, United States, 85724
2
University of California - San Francisco
San Francisco, California, United States, 94143
3
National Jewish Health
Denver, Colorado, United States, 80206
4
Yale University
New Haven, Connecticut, United States, 06510