An interventional study of Ultarthin bronchoscopy with intratumoral washing in Lung Cancer, sponsored by Pusan National University Hospital. Active, not recruiting at 1 site in South Korea. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-03-11.
Sponsored by Pusan National University Hospital · Not applicable, Interventional, and Diagnostic
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Pusan National University Hospital is the lead sponsor of 78 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Age ≥ 20 years
Subjects who withdraw informed consent
Each subject suspected of early-stage lung cancer will undergo bronchooscopic procedure for generic alteration with Next Generation Sequencing.
Diagnostic Test: Ultarthin bronchoscopy with intratumoral washing
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.
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.
Time frame: through study completion, an average of 1 year
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: through study completion, an average of 1 year
Plan to share: No
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This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Pusan National University Hospital