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Completed

NCT Number: NCT01309087

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

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.

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Key information

Conditions

Lung Cancer Behavior Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Smoking Thoracic Neoplasms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of British Columbia, Vancouver, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Primary Lung Cancer

    Time frame: One year from enrollment

Sponsors and collaborators

Lead sponsor

Allegro Diagnostics, Corp.

Industry

Collaborators

  • Beth Israel Deaconess Medical Center
  • Columbia University
  • Georgia Lung Associates PC
  • Indiana University
  • Louisiana State University Health Sciences Center in New Orleans
  • New York University
  • Temple University
  • University of Alabama at Birmingham
  • University of British Columbia
  • University of Dublin, Trinity College
  • University of Missouri-Columbia
  • University of Pennsylvania
  • University of Virginia
  • Vanderbilt University

Registry information

Acronym: AEGIS

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Mar 4, 2011
Registry last updated
Mar 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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