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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01309087

Acronym

AEGIS

Enrollment

756

Registered

2011-03-04

Start date

2009-01-31

Completion date

2013-05-31

Last updated

2014-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

Gene Expression, Lung Cancer, Smoking

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Primary Lung Cancer	One year from enrollment

Countries

Canada, Ireland, United States

Outcome results