Validity of next-generation sequencing (NGS)-based gene panel testing in endoscopic ultrasound with endobronchial ultrasound-guided transbronchial needle aspiration or endobronchial ultrasound-guided transbronchial needle aspiration specimens in patients with lung cancer: a prospective study

Validity of next-generation sequencing (NGS)-based gene panel testing in endoscopic ultrasound with endobronchial ultrasound-guided transbronchial needle aspiration or endobronchial ultrasound-guided transbronchial needle aspiration specimens in patients with lung cancer: a prospective study - Validity of next-generation sequencing (NGS)-based gene panel testing in endoscopic ultrasound with endobronchial ultrasound-guided transbronchial needle aspiration or endobronchial ultrasound-guided transbronchial needle aspiration specimens in patients with lung cancer: a prospective study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000052391

Enrollment

Registered

2023-10-03

Start date

2023-10-03

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 18 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 EBUS-TBNA or 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) Pregnant women or patients who may be pregnant. (ii) Patients who should be analyzed with a gene panel assay other than the Lung Cancer Compact Panel Dx. (iii) Patients with bleeding tendency or unable to discontinue anticoagulants or antiplatelet agents. (iv) Patients deemed inappropriate as research subjects by the principal investigator.

Design outcomes

Primary

Measure	Time frame
Lung cancer compact panel test success rate: Percentage of cases with successful gene panel test in Lung Cancer Compact Panel Dx among those diagnosed with class IV or higher non-small cell lung cancer by EBUS-TBNA or EUS-B-FNA cytology.	—

Secondary

Measure	Time frame
Association between the amount of DNA and RNA extracted in the Lung Cancer Compact Panel Dx and cytological diagnosis of class IV and V. Percentage of tumor cell content using Papanicolaou stained specimens for cytology diagnosis and association with class IV and V in cytology and success rate of the Lung Cancer Compact Panel. At the time of the examination, investigate whether there are any changes in vital signs (e.g., decreased SpO2 or blood pressure changes), uncontrolled bleeding, or other complications that may require interruption of the examination. The presence or absence of complications (e.g., mediastinitis or other serious infections) that may develop late on the day following the examination and one week later will be evaluated.	—

Measure

Time frame

Association between the amount of DNA and RNA extracted in the Lung Cancer Compact Panel Dx and cytological diagnosis of class IV and V. Percentage of tumor cell content using Papanicolaou stained specimens for cytology diagnosis and association with class IV and V in cytology and success rate of the Lung Cancer Compact Panel. At the time of the examination, investigate whether there are any changes in vital signs (e.g., decreased SpO2 or blood pressure changes), uncontrolled bleeding, or other complications that may require interruption of the examination. The presence or absence of complications (e.g., mediastinitis or other serious infections) that may develop late on the day following the examination and one week later will be evaluated.

—

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