Airway Epithelium Gene Expression: AEGIS II
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Lung Cancer |
Device: Biomarker (not used as an intervention) |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Airway Epithelium Gene Expression in the Diagnosis of Lung Cancer: AEGIS II |
- Lung Cancer Diagnosis (positive or negative) [ Time Frame: 12 months ] [ Designated as safety issue: No ]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.
Biospecimen Retention: Samples With DNA
Cells, Blood
| Estimated Enrollment: | 1300 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Standard of Care |
Device: Biomarker (not used as an intervention)
This study is an observational study. There is no intervention.
Other Name: BronchoGen
|
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.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients of enrolled medical centers who are undergoing clinically indicated bronchoscopy for suspect lung cancer and who are current or former cigarette smokers.
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.
Contacts and Locations
Show 21 Study Locations| Study Director: | Duncan Whitney, PhD | Allegro Diagnostics |
More Information
Additional Information:
No publications provided
| Responsible Party: | Allegro Diagnostics, Corp. |
| ClinicalTrials.gov Identifier: | NCT00746759 History of Changes |
| Other Study ID Numbers: | ADx-0001: IDE G090194 |
| Study First Received: | September 3, 2008 |
| Last Updated: | November 12, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration |
Keywords provided by Allegro Diagnostics, Corp.:
|
Lung Cancer Smoker Former Smoker Gene Expression Bronchoscopy |
Additional relevant MeSH terms:
|
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 19, 2013