UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052391 |
|---|---|
| Receipt number | R000059808 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2023/10/03 |
| Last modified on | 2023/10/03 14:14:25 |
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Basic information
Public title
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
Acronym
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
Scientific Title
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
Scientific Title:Acronym
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
Region
| Japan |
Condition
Condition
Primary lung cacner
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to validate cytology specimens by endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) or endoscopic ultrasound with bronchoscope-guided fine needle aspiration (EUS-B-FNA) performed for the diagnosis of lung cancer as specimens for gene panel testing using a next-generation sequencer (Lung Cancer Compact Panel Dx. DNA Chip Research Inc.).
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
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.
Key secondary outcomes
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.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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.
Key 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.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yukihiro |
| Middle name | |
| Last name | Umeda |
Organization
Faculty of Medical Sciences, University of Fukui
Division name
Third Department of Internal Medicine
Zip code
9101193
Address
23-3 Matsuoka-Shimoaizuki, Eiheiji-cho, Fukui
TEL
+81776613111
umeda@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Yukihiro |
| Middle name | |
| Last name | Umeda |
Organization
Faculty of Medical Sciences, University of Fukui
Division name
Third Department of Internal Medicine
Zip code
9101193
Address
23-3 Matsuoka-Shimoaizuki, Eiheiji-cho, Fukui
TEL
+81776613111
Homepage URL
umeda@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
Institute
Department
Personal name
Yukihiro Umeda
Funding Source
Organization
Self founding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Japanese Red Cross Fukui Hospital, Municipal Tsuruga Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Research Ethics Committee of University of Fukui
Address
23-3 Matsuoka-Shimoaizuki, Eiheiji-cho, Fukui
Tel
+81776613111
rinsho-rinri@ml.u-fukui.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
福井赤十字病院（福井県）、市立敦賀病院（福井県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2023 | Year | 10 | Month | 02 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation Items
<Before the examination>
Patient background: gender, age, performance status (ECOG-PS), comorbidities, medical history, smoking history
Confirmation of subjective symptoms: Respiratory symptoms, etc., should be confirmed by interview, etc.
Other findings (vital signs): blood pressure, pulse rate, respiratory rate
Hematological examination: white blood cell count, red blood cell count, hemoglobin, platelet count, PT, APTT
Blood biochemical tests: total protein, albumin, CRP, total bilirubin, AST, ALT, LDH, BUN, Cre
Arterial blood gas or transcutaneous oxygen saturation
Chest CT: puncture site and long/short diameter of puncture lesion
FDG-PET: FDG accumulation in puncture lesion
<During the examination>
Examination time (time from scope insertion to scope removal), sedation dose, number of puncture, site of punctured lesion
Presence or absence of adverse events
<After the examination>
Pathology and cytology diagnosis results of the specimen obtained by EBUS-TBNA or EUS-B-FNA, percentage of tumor cells in the cytology findings (percentage of nuclei of tumor cells among nucleated cells in the tissue)
Clinical stage and TNM classification
Amount of DNA and RNA extracted, percentage of successful analysis, and results of analysis in the Lung Cancer Compact Panel Dx
Management information
Registered date
| 2023 | Year | 10 | Month | 03 | Day |
Last modified on
| 2023 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059808
