Validity of next-generation sequencing (NGS)-based gene panel testing in endoscopic ultrasound with bronchoscope-guided fine needle aspiration (EUS-B-FNA) specimens in patients with lung cancer: a prospective study

Validity of next-generation sequencing (NGS)-based gene panel testing in endoscopic ultrasound with bronchoscope-guided fine needle aspiration (EUS-B-FNA) specimens in patients with lung cancer: a prospective study - Validity of next-generation sequencing (NGS)-based gene panel testing in endoscopic ultrasound with bronchoscope-guided fine needle aspiration (EUS-B-FNA) specimens in patients with lung cancer: a prospective study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000050354

Enrollment

Registered

2023-02-20

Start date

2023-02-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary lung cacner

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (i) Age: Patients who are at least 20 years old at the time of consent. (ii) Gender: any gender (iii) Inpatient/outpatient: Inpatient only (iv) Patients confirmed by prior radiological examination (chest CT, FDG-PET, etc.) to have a lesion strongly suspected to be lung cancer that can be punctured by EUS-B-FNA. (v) Patients who have received a thorough explanation of their participation in this study, and who have given their or their surrogate's written consent based on a thorough understanding of the study.

Exclusion criteria

Exclusion criteria: (i) Patients who are judged by the clinician to have difficulty in transesophageal puncture due to esophageal varices, coagulation abnormalities, etc., based on preliminary examination. (ii) Pregnant women, patients who may be pregnant, or patients who are breast-feeding. (iii) Other patients deemed inappropriate as research subjects by the principal investigator.

Design outcomes

Primary

Measure	Time frame
Specimen adequacy: Tissue area, tumor cell content ratio (percentage of nuclei of tumor cells among nucleated cells in the tissue), and tumor cell count in cases where primary lung cancer was diagnosed by EUS-B-FNA NGS success rate: Percentage of cases with successful gene panel test by Oncomine DxTT among cases diagnosed as non-small cell lung cancer by EUS-B-FNA	—

Secondary

Measure	Time frame
Amount of tissue (DNA, RNA yield) collected by EUS-B-FNA Diagnostic yield and safety of EUS-B-FNA Gene panel test success rate: Percentage of cases with successful gene panel test with Oncomine DxTT or AmoyDx among those diagnosed with non-small cell lung cancer by EUS-B-FNA	—

Countries

Japan

Contacts

Public ContactYukihiro Umeda

Faculty of Medical Sciences, University of Fukui Third Department of Internal Medicine

umeda@u-fukui.ac.jp+81776613111

Outcome results