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

Allegro Diagnostics, Corp.756 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

756

Conditions

Lung Cancer

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. The patient is being evaluated for the diagnosis of possible lung cancer or "rule out lung cancer" and is indicated for bronchoscopy. 2. The patient is undergoing bronchoscopy 3. ≥ 21 years of age 4. Patient meets local site's standard of care (SOC) for performing diagnostic bronchoscopy 5. The patient is a current or former cigarette smoker (defined as having smoked \>100 cigarettes in their lifetime. Exclusion Criteria: 1. The Pulmonary physician does not recommend that bronchoscopy be performed 2. The patient is unable to be consented into the study or unable to comply with requirements of the study 3. The patient has previously been diagnosed with primary lung cancer 4. Immediately prior to bronchoscopy, the patient has been on a mechanical ventilator for ≥ 24 consecutive hours.

Locations (14)

University of Alabama

Birmingham, Alabama, United States

Georgia Lung Associates

Austell, Georgia, United States

Indiana University

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

Primary Lung Cancer

Time frame: One year from enrollment

Data from ClinicalTrials.gov

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