Feasibility of Targeted Bronchial Washing Fluid for Molecular Testing With Next Generation Sequencing in Patients Suspicious of Early-stage Lung Cancer

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

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Diagnostic test: Ultarthin bronchoscopy with intratumoral washing

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Soo Han Kim, MD, PhD; Phone Number: 82-51-240-7889; Email: kshyjt1004@gmail.com
• Study Contact Backup: Name: Jung-Seop Eom, MD, PhD; Phone Number: 82-51-240-7889; Email: ejspulm@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Age ≥ 20 years Obtained written informed consent Subjects suspected with resectable lung cancer and planning to undergo bronchoscopy Subjects with no 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:

Patients who withdraw informed consent Patients who are unable to undergo liquid biopsy (plasma) and tissue biopsy for genetic alteration with Next Generation Sequencing based on the investigator's judgement

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Ultrathin bronchoscopy with intratumoral washing; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Genetic alteration with Next Generation Sequencing detection rate in intratumoral washing fluid	Detection rate is defined as the number of genetic alteration with Next Generation Sequencing detection divided by the total attempts of intratumoral washing by ultrathin bronchoscopy.	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concordance rate of genetic alteration with Next Generation Sequencing detection rate among intratumoral washing fluid, plasma, and tissue	The concordance rate of genetic alteration with Next Generation Sequencing detection rate in intratumoral washing fluid, compared with plasma and tissue (gold standard).	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).	through study completion, an average of 1 year
Genetic alteration with Next Generation Sequencing sensitivity & specificity in intratumoral washing fluid	The sensitivity and specificity of genetic alteration with Next Generation Sequencing in intratumoral washing fluid compared with tissue (gold standard).	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Pusan National University Hospital
• Investigators: Principal Investigator: Jung-Seop Eom, MD, PhD, Pusan National University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 3, 2024
• First Submitted That Met QC Criteria: March 3, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 3, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Lung Cancer; Bronchoscopy; Liquid biopsy; Next Generation Sequencing
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 2402-017-136

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No