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

Not Applicable

Recruiting

• Conditions: Lung Cancer
• Interventions: Diagnostic Test: Ultarthin bronchoscopy with intratumoral washing

• Registration Number: NCT06301295
• Lead Sponsor: Pusan National University Hospital

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.

Study Timeline

• Study First Submitted: 2024-03-03
• Study First Submitted QC: 2024-03-03
• Study First Posted: 2024-03-08
• Study Start: 2024-05-29
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-31
• Last Update Posted: 2024-08-02
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ultrathin bronchoscopy with intratumoral washing	Ultarthin bronchoscopy with intratumoral washing	Each subject suspected of early-stage lung cancer will undergo bronchooscopic procedure for generic alteration with Next Generation Sequencing.

Primary Outcome Measures

Name	Time	Method
The diagnostic accuracy of genetic alterations in intratumoral washing fluid using Next Generation Sequencing	through study completion, an average of 1 year	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.

Secondary Outcome Measures

Name	Time	Method
Detection rate of clinically significant actionable mutations among intratumoral washing fluid, plasma, and tissue	through study completion, an average of 1 year	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).
Sensitivity and specificity of genetic alterations detected by Next Generation Sequencing in intratumoral washing fluid	through study completion, an average of 1 year	The sensitivity and specificity of genetic alterations detected by Next Generation Sequencing in intratumoral washing fluid compared with tissue (gold standard).
Concordance rate of genetic alterations detected by Next Generation Sequencing among intratumoral washing fluid, plasma, and tissue	through study completion, an average of 1 year	The concordance rate of genetic alterations detected by Next Generation Sequencing 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).
Detection rate of co-mutations among intratumoral washing fluid, plasma, and tissue	through study completion, an average of 1 year	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).

Trial Locations

Locations (1)

Pusan National University Hospital; 🇰🇷 Busan, Korea, Republic of