UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050354 |
|---|---|
| Receipt number | R000057339 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2023/02/20 |
| Last modified on | 2024/01/30 08:42:09 |
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Basic information
Public title
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
Acronym
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
Scientific Title
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
Scientific Title:Acronym
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
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 was to validate next-generation sequencing (NGS)-based gene panel testing of endoscopic ultrasound with bronchoscope-guided fine needle aspiration (EUS-B-FNA) specimens in patients with lung cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
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
Key secondary outcomes
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
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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.
Key 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.
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 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui
TEL
+81-(0)776-61-3111
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 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, 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 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, 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 | 02 | Month | 20 | 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
Terminated
Date of protocol fixation
| 2023 | Year | 02 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
Observation Items
<Pre-test>
Patient background: gender, age, height, weight, performance status (PS), comorbidities, medical history, smoking history
Confirmation of subjective symptoms and other findings: confirm respiratory symptoms, etc. by interview, etc.
Vitals: 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, tumor markers
Arterial blood gas or transcutaneous oxygen saturation measurement
Chest CT: long/short diameter of puncture site/puncture lesion
FDG-PET: FDG accumulation in puncture lesion
<During Examination>
Examination time (time from scope insertion to scope removal), sedation dose, number of puncture, site of punctured lesion
presence of adverse events
<After the examination>
Pathology results in the specimen obtained by EUS-B-FNA, tissue area, percentage of tumor cell content (percentage of nuclei of tumor cells among nucleated cells in the tissue), and number of tumor cells in the pathology findings
Amount of DNA and RNA extracted with Oncomaine DxTT, percentage of successful analysis, and results of analysis
Insufficient amount of nucleic acid in OncomaIn DxTT may be analyzed by AmoyDx, success rate of analysis, and results of analysis
Adverse events
Management information
Registered date
| 2023 | Year | 02 | Month | 15 | Day |
Last modified on
| 2024 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057339
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