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

NCT ID: NCT06301295

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-29
• Study Completion Date: 2026-12-31

Brief Summary

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

Detailed Description

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Ultrathin bronchoscopy with intratumoral washing

Each subject suspected of early-stage lung cancer will undergo bronchooscopic procedure for generic alteration with Next Generation Sequencing.

Group Type: EXPERIMENTAL

Ultarthin bronchoscopy with intratumoral washing

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pusan National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jung-Seop Eom, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Pusan National University Hospital

Locations

Pusan National University Hospital

Busan, , South Korea

Countries

South Korea

Other Identifiers

2402-017-136

Identifier Type: -

Identifier Source: org_study_id