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This is a single center, clinical trial evaluating the relevance of intratumoral washing for detection of generic alteration with Next Generation Sequencing.
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 genetic alterations using Next Generation Sequencing in patients suspicious of early-stage lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrathin bronchoscopy with intratumoral washing | Experimental | Each subject suspected of early-stage lung cancer will undergo bronchooscopic procedure for generic alteration with Next Generation Sequencing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultarthin bronchoscopy with intratumoral washing | Diagnostic Test | Each subject suspected of early-stage, resectable lung cancer will undergo bronchooscopic procedure. Ultrathin bronchoscope is inserted and placed within tumor under radial EBUS, virtual bronchoscopic navigation, and fluoroscopy guidance. Subsequently, intratumoral washing is performed. After undergoing surgery for suspected early-stage lung cancer, the analysis of next generation sequencing is conducted on intratumoral washing, tissue from surgical specimen, and blood. |
| Measure | Description | Time Frame |
|---|---|---|
| The diagnostic accuracy of genetic alterations in intratumoral washing fluid using Next Generation Sequencing | Diagnostic accuracy is defined as the number of true positive and true negative genetic alterations detected by Next Generation Sequencing, divided by the total number of intratumoral washing attempts using ultrathin bronchoscopy. | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Detection rate of clinically significant actionable mutations among intratumoral washing fluid, plasma, and tissue | Detection rate is defined as the number of genetic alterations detected by Next Generation Sequencing divided by the total number of intratumoral washing attempts using ultrathin bronchoscopy. Clinically significant actionable mutations are defined as genes with corresponding drugs, either approved or under clinical trial (e.g., EGFR, ALK, ROS1, BRAF V600E, RET, NTRK, KRAS G12C, FGFR3, or HER2). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jung-Seop Eom, MD, 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 |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| through study completion, an average of 1 year |
| Concordance rate of genetic alterations detected by Next Generation Sequencing among intratumoral washing fluid, plasma, and tissue | The concordance rate of genetic alterations detected by Next Generation Sequencing in intratumoral washing fluid, compared with plasma and tissue (gold standard). | through study completion, an average of 1 year |
| Sensitivity and specificity of genetic alterations detected by Next Generation Sequencing in intratumoral washing fluid | The sensitivity and specificity of genetic alterations detected by Next Generation Sequencing in intratumoral washing fluid compared with tissue (gold standard). | through study completion, an average of 1 year |
| Turn-around time | The duration between an order request and the task completion in in intratumoral washing fluid compared with plasma and tissue (gold standard). | through study completion, an average of 1 year |
| Detection rate of co-mutations among intratumoral washing fluid, plasma, and tissue | Detection rate is defined as the number of genetic alterations detected by Next Generation Sequencing divided by the total number of intratumoral washing attempts using ultrathin bronchoscopy. Co-mutations are defined as the occurrence of two or more genetic alterations within the same tumor cells in an individual, including at least one actionable mutation (e.g., TP53, DNMT3A, TET2, CTNNB1, PIK3CA, RB1, STK11). | through study completion, an average of 1 year |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |