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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06301295
• Other study ID #: 2402-017-136
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 29, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2024
• 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 suspicious of early-stage lung cancer.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 98
• 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

1. Inclusion Criteria:

• Age = 20 years

• Obtained written informed consent

• Patients with resectable lung cancer and planning to undergo bronchoscopy

• Patients with no contraindication to brochoscopy

• Patients planning to undergo surgery for suspected lung cancer and opting for tissue or liquid biopsy for genetic alteration using Next Generation Sequencing

2. 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:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The diagnostic accuracy of genetic alterations in intratumoral washing fluid using Next Generation Sequencing	Diagnostic accuracy is defined as the number of true positive and true negative genetic alterations detected by Next Generation Sequencing, divided by the total number of intratumoral washing attempts using ultrathin bronchoscopy.	through study completion, an average of 1 year
Secondary	Detection rate of clinically significant actionable mutations among intratumoral washing fluid, plasma, and tissue	Detection rate is defined as the number of genetic alterations detected by Next Generation Sequencing divided by the total number of intratumoral washing attempts using ultrathin bronchoscopy. Clinically significant actionable mutations are defined as genes with corresponding drugs, either approved or under clinical trial (e.g., EGFR, ALK, ROS1, BRAF V600E, RET, NTRK, KRAS G12C, FGFR3, or HER2).	through study completion, an average of 1 year
Secondary	Concordance rate of genetic alterations detected by Next Generation Sequencing among intratumoral washing fluid, plasma, and tissue	The concordance rate of genetic alterations detected by Next Generation Sequencing in intratumoral washing fluid, compared with plasma and tissue (gold standard).	through study completion, an average of 1 year
Secondary	Sensitivity and specificity of genetic alterations detected by Next Generation Sequencing in intratumoral washing fluid	The sensitivity and specificity of genetic alterations detected by Next Generation Sequencing in intratumoral washing fluid compared with 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	Detection rate of co-mutations among intratumoral washing fluid, plasma, and tissue	Detection rate is defined as the number of genetic alterations detected by Next Generation Sequencing divided by the total number of intratumoral washing attempts using ultrathin bronchoscopy. Co-mutations are defined as the occurrence of two or more genetic alterations within the same tumor cells in an individual, including at least one actionable mutation (e.g., TP53, DNMT3A, TET2, CTNNB1, PIK3CA, RB1, STK11).	through study completion, an average of 1 year