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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06141005
• Other study ID #: 2310-011-132
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 30, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: November 2023
• Source: Pusan National University Hospital
• Contact: Jung-Seop Eom, MD, PhD
• Phone: 82-51-240-7889
• Email: ejspulm[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 93
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University hospital	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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