Airway Epithelium Gene Expression: AEGIS IDE (AEGIS IDE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00746759|
Recruitment Status : Completed
First Posted : September 4, 2008
Last Update Posted : June 4, 2015
|Condition or disease||Intervention/treatment|
|Lung Cancer||Device: Biomarker (not used as an intervention)|
|Study Type :||Observational|
|Actual Enrollment :||1331 participants|
|Official Title:||Airway Epithelium Gene Expression in the Diagnosis of Lung Cancer: AEGIS IDE|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||February 2015|
|Standard of Care||
Device: Biomarker (not used as an intervention)
This study is an observational study. There is no intervention.
Other Name: BronchoGen
- Lung Cancer Diagnosis (positive or negative) [ Time Frame: 12 months ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00746759
|Study Director:||Duncan Whitney, PhD||Allegro Diagnostics|