Validity of next-generation sequencing (NGS)-based gene panel testing in endoscopic ultrasound with bronchoscope-guided fine needle aspiration (EUS-B-FNA) specimens in patients with lung cancer: a prospective study
Not Applicable
- Conditions
- Primary lung cacner
- Registration Number
- JPRN-UMIN000050354
- Lead Sponsor
- niversity of Fukui
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
(i) Patients who are judged by the clinician to have difficulty in transesophageal puncture due to esophageal varices, coagulation abnormalities, etc., based on preliminary examination. (ii) Pregnant women, patients who may be pregnant, or patients who are breast-feeding. (iii) Other patients deemed inappropriate as research subjects by the principal investigator.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Specimen adequacy: Tissue area, tumor cell content ratio (percentage of nuclei of tumor cells among nucleated cells in the tissue), and tumor cell count in cases where primary lung cancer was diagnosed by EUS-B-FNA NGS success rate: Percentage of cases with successful gene panel test by Oncomine DxTT among cases diagnosed as non-small cell lung cancer by EUS-B-FNA
- Secondary Outcome Measures
Name Time Method Amount of tissue (DNA, RNA yield) collected by EUS-B-FNA Diagnostic yield and safety of EUS-B-FNA Gene panel test success rate: Percentage of cases with successful gene panel test with Oncomine DxTT or AmoyDx among those diagnosed with non-small cell lung cancer by EUS-B-FNA