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Completed

NCT Number: NCT00746759

Airway Epithelium Gene Expression: AEGIS IDE

The purpose of the research study is to develop a new, more sensitive, and less invasive test for diagnosing lung cancer at an earlier stage, when it can more easily be cured. The investigators hypothesize that certain genes are expressed differently in current and former smokers who have lung cancer, and this difference in gene expression may be a biomarker for lung cancer.

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Key information

Conditions

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

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama, Birmingham, Alabama, United States

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About this study

Allegro Diagnostics is funding this multi-center study to validate and extend a new diagnostic tool measuring global gene expression in airway epithelial cells obtained at routine bronchoscopy in suspect lung cancer patients. The test, which is highly sensitive and specific for lung cancer, measures the levels of expression of genes in cells brushed from the large bronchi during diagnostic bronchoscopy. Similar brushings of epithelial cells from the nose will be analyzed to determine if gene expression in these cells can be used as a screening tool in subjects who may have now or be at risk for developing lung cancer in the future.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients being evaluated for the diagnosis of possible lung cancer or "rule out lung cancer" and undergoing clinically indicated bronchoscopy
  • All patients are required to be at least 21 years of age and be able to understand and sign the informed consent form
  • Patient must be a current or former cigarette smoker

Exclusion criteria

  • A pulmonary physician does not recommend that bronchoscopy be performed
  • Inability to understand the written consent form and comply with requirements of the study
  • History of prior primary lung cancer
  • Immediately prior to bronchoscopy, the patient has been on a mechanical ventilator for >24 consecutive hours.

Treatment and study plan

Biomarker (not used as an intervention)

Device

This study is an observational study. There is no intervention.

Other names: BronchoGen

Primary outcomes

  1. Lung Cancer Diagnosis (positive or negative)

    Time frame: 12 months

    Patients may be followed at 12 months post bronchoscopy to finalize diagnosis if diagnosis had not previously been confirmed. The biomarker score will be compared to the standard diagnosis to evaluate the sensitivity, specificity, and negative predictive values of the biomarker.

Sponsors and collaborators

Lead sponsor

Allegro Diagnostics, Corp.

Industry

Collaborators

  • Columbia University
  • Indiana University
  • Jamaica Hospital Medical Center
  • Louisiana State University Health Sciences Center in New Orleans
  • Medical University of South Carolina
  • National Jewish Health
  • North Florida/South Georgia Veterans Health System
  • Overlake Hospital Bellevue WA
  • Pulmonary Associates of Arizona
  • Pulmonary and Allergy Associates of New Jersey
  • Steward St. Elizabeth's Medical Center of Boston, Inc.
  • Temple University
  • The Cleveland Clinic
  • University of Alabama at Birmingham
  • University of California, Davis
  • University of Missouri-Columbia
  • University of Pennsylvania
  • University of Wisconsin, Madison
  • Virginia Commonwealth University
  • William Jennings Bryan Dorn VA Medical Center
  • Yale University

Registry information

Official study title

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

Acronym: AEGIS IDE

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
Sep 4, 2008
Registry last updated
Jun 4, 2015

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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