Lung Cancer Clinical Trial
Airway Epithelium Gene Expression: AEGIS IDE
Summary
The purpose of the research study is to develop a new, more sensitive, and less invasive test for diagnosing lung cancer at an earlier stage, when it can more easily be cured. The investigators hypothesize that certain genes are expressed differently in current and former smokers who have lung cancer, and this difference in gene expression may be a biomarker for lung cancer.
Full Description
Allegro Diagnostics is funding this multi-center study to validate and extend a new diagnostic tool measuring global gene expression in airway epithelial cells obtained at routine bronchoscopy in suspect lung cancer patients. The test, which is highly sensitive and specific for lung cancer, measures the levels of expression of genes in cells brushed from the large bronchi during diagnostic bronchoscopy. Similar brushings of epithelial cells from the nose will be analyzed to determine if gene expression in these cells can be used as a screening tool in subjects who may have now or be at risk for developing lung cancer in the future.
Eligibility Criteria
Inclusion Criteria:
Patients being evaluated for the diagnosis of possible lung cancer or "rule out lung cancer" and undergoing clinically indicated bronchoscopy
All patients are required to be at least 21 years of age and be able to understand and sign the informed consent form
Patient must be a current or former cigarette smoker
Exclusion Criteria:
A pulmonary physician does not recommend that bronchoscopy be performed
Inability to understand the written consent form and comply with requirements of the study
History of prior primary lung cancer
Immediately prior to bronchoscopy, the patient has been on a mechanical ventilator for >24 consecutive hours.
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There are 18 Locations for this study
Birmingham Alabama, 35294, United States
Phoenix Arizona, 85006, United States
Sacramento California, , United States
Denver Colorado, 80206, United States
New Haven Connecticut, , United States
Gainesville Florida, 32608, United States
Indianapolis Indiana, 46202, United States
New Orleans Louisiana, 70112, United States
Boston Massachusetts, 02135, United States
Columbia Missouri, 65203, United States
Summit New Jersey, 07901, United States
Jamaica New York, 11418, United States
New York New York, 10032, United States
Cleveland Ohio, , United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19140, United States
Charleston South Carolina, 29425, United States
Columbia South Carolina, 29209, United States
Richmond Virginia, 23298, United States
Bellevue Washington, 98004, United States
Madison Wisconsin, 53792, United States
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