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The purpose of this study is to evaluate the relevance of intratumoral washing for detection of EGFR mutation (including T790M positivity).
This is a prospective, single-arm, open-label study to assess evaluate the relevance of intratumoral washing by ultrathin bronchoscopy (outer diameter; 3mm) for detection of EGFR mutation (including T790M positivity) using cobas real-time PCR and droplet digital PCR (DDPCR) in patients with NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrathin bronchoscopy with intratumoral washing | Experimental | Each subject with NSCLC will undergo bronchooscopic procedure for EGFR mutation (including T790M positivity) evaluation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultarthin bronchoscopy with intratumoral washing | Diagnostic Test | Each subject with NSCLC will undergo bronchooscopic procedure. First, ultrathin bronchoscope is inserted and placed within tumor under radial EBUS, virtual bronchoscopic navigation, and fluoroscopy guidance. Then, intratumoral washing is performed. Subsequently, transbronchial lung biopsy is performed under radial EBUS, virtual bronchoscopic navigation, and fluoroscopy guidance. |
| Measure | Description | Time Frame |
|---|---|---|
| The DNA and EGFR mutation (including T790M positivity) detection rate in intratumoral washing fluid | Defined as the number of DNA and EGFR mutation (including T790M positivity) detection divided by the total attempts of intratumoral washing by ultrathin bronchoscopy. | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The concordance rate of EGFR mutation (including T790M positivity) detection rate among intratumoral washing fluid, plasma, and tissue | The concordance rate of EGFR mutation (including T790M positivity) detection rate in intratumoral washing fluid, compared with plasma and tissue (gold standard). | through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mi-Hyun Kim, PhD | Pusan National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University hospital | Busan | South Korea |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| The EGFR mutation (including T790M positivity) sensitivity and specificity in intratumoral washing fluid | The sensitivity and specificity of EGFR mutation (including T790M positivity) in intratumoral washing fluid compared with tissue (gold standard). | through study completion, an average of 1 year |
| Objective response rate | Objective response rate (ORR) including rate of complete response (CR) and partial response (PR) based on RECIST 1.1. | through study completion, an average of 1 year |
| Disease control rate | Disease control rate (DCR) including rate of CR, PR and stable disease (SD) based on RECIST 1.1. | through study completion, an average of 1 year |
| Progression-free survival | Progression-free survival (PFS) the time from first dose of the study drug until the date of progressive disease (PD) based on RECIST 1.1 or death by any cause. | through study completion, an average of 1 year |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |