Airway Epithelium Gene Expression: AEGIS IDE
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Airway Epithelium Gene Expression in the Diagnosis of Lung Cancer: AEGIS IDE|
- Lung Cancer Diagnosis (positive or negative) [ Time Frame: 12 months ] [ Designated as safety issue: No ]Patients may be followed at 12 months post bronchoscopy to finalize diagnosis if diagnosis had not previously been confirmed. The biomarker score will be compared to the standard diagnosis to evaluate the sensitivity, specificity, and negative predictive values of the biomarker.
Biospecimen Retention: Samples With DNA
|Study Start Date:||February 2010|
|Study Completion Date:||February 2015|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
|Standard of Care||
Device: Biomarker (not used as an intervention)
This study is an observational study. There is no intervention.
Other Name: BronchoGen
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00746759
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|Study Director:||Duncan Whitney, PhD||Allegro Diagnostics|