Lung Cancer
Conditions
Keywords
Lung Cancer, Smoker, Former Smoker, Gene Expression, Bronchoscopy
Brief summary
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.
Detailed description
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.
Interventions
DEVICEBiomarker (not used as an intervention)
This study is an observational study. There is no intervention.
Sponsors
University of Pennsylvania
Columbia University
Temple University
Indiana University
University of Alabama at Birmingham
University of Missouri-Columbia
Louisiana State University Health Sciences Center in New Orleans
University of Wisconsin, Madison
Medical University of South Carolina
National Jewish Health
Overlake Hospital Bellevue WA
Pulmonary and Allergy Associates of New Jersey
Pulmonary Associates of Arizona
William Jennings Bryan Dorn VA Medical Center
Virginia Commonwealth University
Jamaica Hospital Medical Center
North Florida/South Georgia Veterans Health System
Steward St. Elizabeth's Medical Center of Boston, Inc.
University of California, Davis
Yale University
The Cleveland Clinic
Allegro Diagnostics, Corp.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lung Cancer Diagnosis (positive or negative) | 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. |
Countries
United States
Outcome results
None listed