Feasibility of Bronchial Washing Fluid for Molecular Testing with Next Generation Sequencing in Lung Cancer
- Conditions
- Lung Cancer
- Interventions
- Diagnostic Test: Ultrathin bronchoscopy with intratumoral washing
- Registration Number
- NCT06141005
- 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 with NSCLC.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 65
- Age ≥ 20 years
- Obtained written informed consent
- No contraindication to bronchoscopy
- Subjects suspected of having lung cancer on computed tomography or diagnosed with lung cancer by histology or cytology
- Subjects planning to undergo tissue or liquid biopsy for genetic alteration with Next Generation Sequencing
- 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 Ultrathin bronchoscopy with intratumoral washing Each subject suspected or diagnosed of lung cancer will undergo bronchoscopic procedure for generic alteration with Next Generation Sequencing.
- Primary Outcome Measures
Name Time Method Comparison of the detection rate of druggable genetic alteration using Next Generation Sequencing in bronchial washing fluid, tissue, and plasma across the full patient set through study completion, an average of 1 year Detection rate of druggable genetic alteration is defined as the number of true positive druggable genetic alterations detected by Next Generation Sequencing, divided by the total number of attempts. Druggable mutations were defined the presence of following genetic alterations: 1) EGFR mutation, 2) KRAS G12C mutation, 3) ALK rearrangement, 4) ROS1 rearrangement, 5) BRAF V600E mutation, 6) NTRK1/2/3 gene fusion, 7) METex14 skipping mutation, 8) RET rearrangement and 9) ERBB2 (HER2) mutation. The full patient set included all enrolled subjects.
- Secondary Outcome Measures
Name Time Method The concordance rate for the detection of druggable genetic mutations among bronchial washing fluid, plasma, and tissue samples using Next Generation Sequencing in the analysis intent group through study completion, an average of 1 year The concordance rate of druggable genetic alterations detected in bronchial washing fluid by Next Generation Sequencing is compared with that in plasma and tissue in the analysis intent group. Druggable mutations were defined the presence of following genetic alterations: 1) EGFR mutation, 2) KRAS G12C mutation, 3) ALK rearrangement, 4) ROS1 rearrangement, 5) BRAF V600E mutation, 6) NTRK1/2/3 gene fusion, 7) METex14 skipping mutation, 8) RET rearrangement and 9) ERBB2 (HER2) mutation. The analysis intent group consisted of the subset of subjects for whom Next Generation Sequencing testing was successfully performed with tissue samples.
Comparisons of the detection rates of representative co-occurring genetic alterations in bronchial washing, plasma, and tissue samples across the full patient set through study completion, an average of 1 year Detection rate of co-occuring genetic alteration is defined as the number of true positive co-occurring genetic alterations detected by Next Generation Sequencing, divided by the total number of attempts. Co-occurring genetic alterations were defined as the presence of following GAs: 1) ATM mutation, 2) CDKN2A mutation, 3) CTNNB1 mutation, 4) FGFR1 mutation, 5) KEAP1 mutation, 6) MDM2 amplification, 7) MET amplification, 8) MYC amplification, 9) PIK3CA mutation 10) RB1 mutation, 11) STK11 mutation and 12) TP53 mutation. The full patient set included all enrolled subjects.
The incidence of adverse events associated with the bronchial washing procedure through study completion, an average of 1 year The frequency and severity of adverse events resulting from bronchial washing procedures
Trial Locations
- Locations (1)
Pusan National University hospital
🇰🇷Busan, Korea, Republic of