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

NCT06301295 | Active Not Recruiting

• 1 other identifier: 2402-017-136
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lung Cancer

Keywords

Bronchoscopy; Liquid biopsy; Lung Cancer; Next Generation Sequencing

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Detection rate of clinically significant actionable mutations among intratumoral washing fluid, plasma, and tissue

  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

  through study completion, an average of 1 year

• Sensitivity and specificity of genetic alterations detected by Next Generation Sequencing in intratumoral washing fluid

  through study completion, an average of 1 year

• Turn-around time

  through study completion, an average of 1 year

• Detection rate of co-mutations among intratumoral washing fluid, plasma, and tissue

  through study completion, an average of 1 year

Study Arms (1)

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.

Diagnostic Test: Ultarthin bronchoscopy with intratumoral washing

Interventions

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.

Ultrathin bronchoscopy with intratumoral washing

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pusan National University Hospital: lead

Study Sites (1)

Pusan National University Hospital

Busan, South Korea

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jung-Seop Eom, MD, PhD

  Pusan National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2024
• First Posted: March 8, 2024
• Study Start: May 29, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 11, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)