Airway Epithelium Gene Expression in the Diagnosis of Lung Cancer: AEGIS CLIA

Allegro Diagnostics, Corp.14 sites in 3 countries756 target enrollmentJanuary 2009

ConditionsLung Cancer

Overview

Phase: N/A
Intervention: Not specified
Conditions: Lung Cancer
Sponsor: Allegro Diagnostics, Corp.
Enrollment: 756
Locations: 14
Primary Endpoint: Primary Lung Cancer
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this study is to substantiate prediction accuracy(with a tighter 95% confidence interval compared to current diagnostic modalities), of a lung cancer biomarker for risk stratification of patients into high and low risk categories to aid in clinical evaluation of the patient.

Registry

clinicaltrials.gov

Start Date

January 2009

End Date

May 2013

Last Updated

12 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Allegro Diagnostics, Corp.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The patient is being evaluated for the diagnosis of possible lung cancer or "rule out lung cancer" and is indicated for bronchoscopy.
•The patient is undergoing bronchoscopy
•≥ 21 years of age
•Patient meets local site's standard of care (SOC) for performing diagnostic bronchoscopy
•The patient is a current or former cigarette smoker (defined as having smoked \>100 cigarettes in their lifetime.

Exclusion Criteria

•The Pulmonary physician does not recommend that bronchoscopy be performed
•The patient is unable to be consented into the study or unable to comply with requirements of the study
•The patient has previously been diagnosed with primary lung cancer
•Immediately prior to bronchoscopy, the patient has been on a mechanical ventilator for ≥ 24 consecutive hours.