Feasibility of Bronchial Washing Fluid for Molecular Testing With Next Generation Sequencing in Lung Cancer

NCT06141005 | Completed

• 1 other identifier: 2310-011-132
• Study Type: interventional
• Target: 65
• 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)

• Comparison of the detection rate of druggable genetic alteration using Next Generation Sequencing in bronchial washing fluid, tissue, and plasma across the full patient set

  Detection rate of druggable genetic alteration is defined as the number of true positive druggable genetic alterations detected by Next Generation Sequencing, divided by the total number of attempts. Druggable mutations were defined the presence of following genetic alterations: 1) EGFR mutation, 2) KRAS G12C mutation, 3) ALK rearrangement, 4) ROS1 rearrangement, 5) BRAF V600E mutation, 6) NTRK1/2/3 gene fusion, 7) METex14 skipping mutation, 8) RET rearrangement and 9) ERBB2 (HER2) mutation. The full patient set included all enrolled subjects.

  through study completion, an average of 1 year

Secondary Outcomes (3)

• The concordance rate for the detection of druggable genetic mutations among bronchial washing fluid, plasma, and tissue samples using Next Generation Sequencing in the analysis intent group

  through study completion, an average of 1 year

• Comparisons of the detection rates of representative co-occurring genetic alterations in bronchial washing, plasma, and tissue samples across the full patient set

  through study completion, an average of 1 year

• The incidence of adverse events associated with the bronchial washing procedure

  through study completion, an average of 1 year

Study Arms (1)

Ultrathin bronchoscopy with intratumoral washing

EXPERIMENTAL

Each subject suspected or diagnosed of lung cancer will undergo bronchoscopic procedure for generic alteration with Next Generation Sequencing.

Diagnostic Test: Ultrathin bronchoscopy with intratumoral washing

Interventions

Ultrathin bronchoscopy with intratumoral washing DIAGNOSTIC_TEST

Each subject suspected or diagnosed of lung cancer will undergo bronchoscopic 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.

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
• No contraindication to bronchoscopy
• Subjects suspected of having lung cancer on computed tomography or diagnosed with lung cancer by histology or cytology
• Subjects planning to undergo tissue or liquid biopsy for genetic alteration with 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, 49241, 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: November 3, 2023
• First Posted: November 21, 2023
• Study Start: November 30, 2023
• Primary Completion: August 29, 2024
• Study Completion: December 31, 2024
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)