Clinical trial · Observational
Airway Epithelium Gene Expression: AEGIS IDE
Airway Epithelium Gene Expression in the Diagnosis of Lung Cancer: AEGIS IDE
NCT00746759CI-TRIAL-00018144AEGIS IDEcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biomarker (not used as an intervention) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Standard of Care
- interventionNames
- Device: Biomarker (not used as an intervention)
Primary outcomes (1)
- measure
- Lung Cancer Diagnosis (positive or negative)
- timeFrame
- 12 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDVachani A, Whitney DH, Parsons EC, Lenburg M, Ferguson JS, Silvestri GA, Spira A. Clinical Utility of a Bronchial Genomic Classifier in Patients With Suspected Lung Cancer. Chest. 2016 Jul;150(1):210-8. doi: 10.1016/j.chest.2016.02.636. Epub 2016 Feb 16. PMID 26896702
- DERIVEDSilvestri GA, Vachani A, Whitney D, Elashoff M, Porta Smith K, Ferguson JS, Parsons E, Mitra N, Brody J, Lenburg ME, Spira A; AEGIS Study Team. A Bronchial Genomic Classifier for the Diagnostic Evaluation of Lung Cancer. N Engl J Med. 2015 Jul 16;373(3):243-51. doi: 10.1056/NEJMoa1504601. Epub 2015 May 17. PMID 25981554