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The purpose of this study is to learn if chemicals from the mouth or stomach can be found in the lungs. This may suggest a process called aspiration. This study may help us understand if aspiration plays a role in different lung diseases.
This study is a single center, prospective, observational study of determining pepsin levels in BALF samples obtained from consecutive bronchoscopies at the Mayo Clinic Jacksonville. It is inherently an exploratory pilot study to confirm whether pepsin in BAL can act as a marker of gastric to pulmonary aspiration and whether specific association to pulmonary pathologies can be identified.
As an overview, all patients who are undergoing a bronchoscopy for clinical indications will be screened for potential participation in the study by obtaining BALF samples during the procedure for laboratory analyses. The BALF will then be tested for pepsin at the Thoracic Diseases Research Unit (Mayo Clinic Rochester) using a commercially available ELISA kit, and the ancillary markers will be analyzed per the clinical laboratory. Internal controls will be defined as normals when subjects have no lung dysfunction, no respiratory symptoms, and no lung parenchymal infiltrates on chest radiographs.
The primary aims of this project parallels the short-term hypotheses stated above:
Secondary aims of the study will include exploratory analyses of lesser defined potential aspiration markers including bilirubin, lipase, amylase, and pepsinogen. Analyses of these markers will parallel the analyses performed for pepsin.
The focus of the study is to:
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Inclusion Criteria:
Exclusion Criteria:
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All subjects will be recruited from the Mayo Clinic Jacksonville site. As defined in the inclusion criteria, patients will only be identified once they are scheduled for a bronchoscopy for clinical indications. Only adult patients will be considered, and there will be no regard to gender or ethnicity in the screening or selection. The BAL procedure may or may not be requested by the referring clinician as part of the patient's bronchoscopy. In those subjects where the BAL is not requested for clinical indications, that means the BAL will be an additional procedure to be added to the patient's bronchoscopy for research purposes. Both patients in the inpatient and outpatient settings will be recruited, but emergent or operating room based bronchoscopies will be excluded. The specific inclusion and exclusion criteria are listed below.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Jacksonville | Florida | 32224 | United States |
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BALF specimens will be collected by the MCF Biospecimen Facility at the time of the bronchoscopy. A minimum of 5 mL will be collected. Specimen processing will include centrifugation to separate the cell pellet from the supernatant. The supernatant will be stored in 2 mL cryovials, and stored at -70°C until time of testing for the pepsin-ELISA. Storage will allow retesting at another date if the assay is modified or if another substance of interest arises in the course of the study that requires re-testing of the specimens. The clinical sample will also be tested through the Mayo Clinic medical laboratory for bilirubin, pepsinogen, amylase, and lipase.