Ireland
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Active, not recruiting Not applicable

Feasibility of Targeted Bronchial Washing for Molecular Testing by Next Generation Sequencing in Early-stage Lung Cancer

NCT06301295 · tracked via the Priya Life Science South Korea tracker
Phase
Not applicable
Started
2024-05-29
Last updated
2026-03-11

Condition(s) studied

Lung Cancer

Investigational drug(s) / intervention(s)

Ultarthin bronchoscopy with intratumoral washing

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.

Study summary

This is a single center, clinical trial evaluating the relevance of intratumoral washing for detection of generic alteration with Next Generation Sequencing.

Eligibility

Sex
ALL
Min age
20 Years
Max age
—
Healthy volunteers
No
1. Inclusion Criteria: * Age ≥ 20 years * Obtained written informed consent * Subjects suspected of having resectable lung cancer on computed tomography * Subjects without contraindication to brochoscopy * Subjects planning to undergo surgery for suspected lung cancer and opting for tissue or liquid biopsy for genetic alteration using Next Generation Sequencing 2. Exclusion Criteria: * Subjects who withdraw informed consent * Subjects who are unable to undergo liquid biopsy (plasma) and tissue biopsy - for genetic alteration with Next Generation Sequencing based on the investigator's judgement * Subjects diagnosed with a cancer other than non-small cell lung cancer from the lung tissue lesion * Subjects diagnosed with a benign lesion from the lung tissue lesion

Primary outcome measure(s)

  • The diagnostic accuracy of genetic alterations in intratumoral washing fluid using Next Generation Sequencing — through study completion, an average of 1 year
    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.

Trial sites (1)

FacilityCityRegionStatus
Pusan National University Hospital Busan South Korea
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06301295 on ClinicalTrials.gov ↗ ← All trials in South Korea