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Bronchogen

Ala-Glu-Asp-Leu, AEDL

Quick Stats
Studies 10
Trials 30
Completed OBSERVATIONAL NCT00746759

Airway Epithelium Gene Expression: AEGIS IDE

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

Detailed 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.

Interventions

Name: Biomarker (not used as an intervention)
Type: DEVICE
Description: This study is an observational study. There is no intervention.

Primary Outcomes

Measure: Lung Cancer Diagnosis (positive or negative)
TimeFrame: 12 months
Description: 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.

Trial Information

NCT ID

NCT00746759

Status

Completed

Study Type

OBSERVATIONAL

Sponsor

Allegro Diagnostics, Corp.

Last Updated

December 15, 2025