Validity of next-generation sequencing (NGS)-based gene panel testing in endoscopic ultrasound with endobronchial ultrasound-guided transbronchial needle aspiration or endobronchial ultrasound-guided transbronchial needle aspiration specimens in patients with lung cancer: a prospective study
Not Applicable
Recruiting
- Conditions
- Primary lung cacner
- Registration Number
- JPRN-UMIN000052391
- Lead Sponsor
- niversity of Fukui
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
(i) Pregnant women or patients who may be pregnant. (ii) Patients who should be analyzed with a gene panel assay other than the Lung Cancer Compact Panel Dx. (iii) Patients with bleeding tendency or unable to discontinue anticoagulants or antiplatelet agents. (iv) 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 ung cancer compact panel test success rate: Percentage of cases with successful gene panel test in Lung Cancer Compact Panel Dx among those diagnosed with class IV or higher non-small cell lung cancer by EBUS-TBNA or EUS-B-FNA cytology.
- Secondary Outcome Measures
Name Time Method Association between the amount of DNA and RNA extracted in the Lung Cancer Compact Panel Dx and cytological diagnosis of class IV and V. Percentage of tumor cell content using Papanicolaou stained specimens for cytology diagnosis and association with class IV and V in cytology and success rate of the Lung Cancer Compact Panel. At the time of the examination, investigate whether there are any changes in vital signs (e.g., decreased SpO2 or blood pressure changes), uncontrolled bleeding, or other complications that may require interruption of the examination. The presence or absence of complications (e.g., mediastinitis or other serious infections) that may develop late on the day following the examination and one week later will be evaluated.