Clinical Trial: Bronchoscopy Assisted by Electromagnetic Navigation (EMN) in the Diagnosis of Small Pulmonary Nodules

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Role of Bronchoscopy Assisted by Electromagnetic Navigation (EMN) in the Diagnosis of Small Pulmonary Nodules of Indeterminate Nature. A Prospective Study by the European

Brief Summary: Due to CT screening, a lot of peripheral nodule not accessible to conventional endoscopy will be found. Electromagnetic navigation directed bronchoscopy (ENB) is a new technique needing validation. the primary aim of the study is to compare ENB to radiologically guided bronchoscopy, considered the standard comparator.

Detailed Summary:
Sponsor: European Lung Cancer Working Party

Current Primary Outcome: Capability of diagnosing lung nodule with ENB (Sensitivity) [ Time Frame: After the procedure ]

Calculate the sensitivity of each endoscopic technique in obtaining the diagnostic of the pulmonary nodule


Original Primary Outcome: Same as current

Current Secondary Outcome: Prediction of malignancy [ Time Frame: After the procedure ]

To identify a predictive molecular signature able to predict the malignant nature of the nodule by studying the transcriptome (miRNAs and mRNAs) and the single nucleotide polymorphism (SNPs) by using high throughput techniques in biopsies, alveolar lavage, blood and exhaled breath


Original Secondary Outcome: Same as current

Information By: European Lung Cancer Working Party

Dates:
Date Received: January 28, 2013
Date Started: January 2013
Date Completion: December 2019
Last Updated: August 9, 2016
Last Verified: August 2016