Observational study to investigate the execution rate of re-biopsy and the concordance rate for T790M mutation detection by the Cobas test between histological and cytological samples in EGFR-TKI-resistant patients with EGFR mutation-positive advanced non-small cell lung cancer
Not Applicable
- Conditions
- on-small cell lung cancer
- Registration Number
- JPRN-UMIN000026019
- Lead Sponsor
- iigata Lung Cancer Treatment Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
Treatment by 3rd generation EGFR-TKI
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Execution rate of re-biopsy in secondarily registered patients Concordance rate for T790M mutation detection by the Cobas test between histological and cytological samples.
- Secondary Outcome Measures
Name Time Method Success rate of re-biopsy (= Number of patients with detected cancer cells / Number of re-biopsies performed), Individual test modalities (for bronchoscopy, confirm whether EBUS-TBNA or EBUS-GS has been performed or not) / Positive T790M mutation rate by biopsy site (= Number of patients with positive T790M mutation / Number of patients with detected cancer cells), Safety of individual test modalities, Analysis of reasons for patients not undergoing re-biopsy after secondary registration, Execution rate of re-biopsy by use or non-use of each test modality (e.g., EBUS-TBNA, EBUS-GS, CT-guided biopsy), Investigation of prognosis at 1 year after secondary registration (including the type of subsequent treatment)