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

Sponsor

Pusan National University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06141005

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Diagnostic Test: Ultrathin bronchoscopy with intratumoral washing	N/A

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 with NSCLC.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

93 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Nov 30, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ultrathin bronchoscopy with intratumoral washing 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 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.

Arm

Intervention/Treatment

Experimental: Ultrathin bronchoscopy with intratumoral washing

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

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.

Outcome Measures

Primary Outcome Measures

Genetic alteration with Next Generation Sequencing detection rate in intratumoral washing fluid [through study completion, an average of 1 year]
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.

Secondary Outcome Measures

Concordance rate of genetic alteration with Next Generation Sequencing detection rate among intratumoral washing fluid, plasma, and tissue [through study completion, an average of 1 year]
The concordance rate of genetic alteration with Next Generation Sequencing detection rate in intratumoral washing fluid, compared with plasma and tissue (gold standard).
Turn-around time [through study completion, an average of 1 year]
The duration between an order request and the task completion in in intratumoral washing fluid compared with plasma and tissue (gold standard).
Genetic alteration with Next Generation Sequencing sensitivity & specificity in intratumoral washing fluid [through study completion, an average of 1 year]
The sensitivity and specificity of genetic alteration with Next Generation Sequencing in intratumoral washing fluid compared with tissue (gold standard).

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥ 20 years
Obtained written informed consent
Subjects suspected with lung cancer on computed tomography or diagnosed with lung cancer by histology or cytology
Subjects who plan to undergo tissue or liquid biopsy for genetic alteration with 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pusan National University hospital	Busan		Korea, Republic of	49241

Sponsors and Collaborators

Pusan National University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pusan National University Hospital

ClinicalTrials.gov Identifier:

NCT06141005

Other Study ID Numbers:

2310-011-132

First Posted:

Nov 21, 2023

Last Update Posted:

Nov 21, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Pusan National University Hospital

Bronchoscopy

Liquid biopsy

Lung Cancer

Next Generation Sequencing

Additional relevant MeSH terms:

Lung Neoplasms

Study Results

No Results Posted as of Nov 21, 2023