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

Allegro Diagnostics

Status: Completed

Conditions: Lung Cancer

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01309087

ADx-0001: AEGIS CLIA

Details and patient eligibility

About

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.

Enrollment: 756 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.