UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041235 |
|---|---|
| Receipt number | R000047088 |
| Scientific Title | Diagnostic efficacy and safety of transesophageal endoscopic ultrasound with bronchoscope-guided fine needle aspiration (EUS-B-FNA) for the patients with lung cancer with respiratory failure |
| Date of disclosure of the study information | 2020/07/28 |
| Last modified on | 2023/07/31 12:44:53 |
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Basic information
Public title
Diagnostic efficacy and safety of transesophageal endoscopic ultrasound with bronchoscope-guided fine needle aspiration (EUS-B-FNA) for the patients with lung cancer with respiratory failure
Acronym
Diagnostic efficacy and safety of transesophageal endoscopic ultrasound with bronchoscope-guided fine needle aspiration (EUS-B-FNA) for the patients with lung cancer with respiratory failure
Scientific Title
Diagnostic efficacy and safety of transesophageal endoscopic ultrasound with bronchoscope-guided fine needle aspiration (EUS-B-FNA) for the patients with lung cancer with respiratory failure
Scientific Title:Acronym
Diagnostic efficacy and safety of transesophageal endoscopic ultrasound with bronchoscope-guided fine needle aspiration (EUS-B-FNA) for the patients with lung cancer with respiratory failure
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the diagnostic efficacy and safety of transesophageal bronchoscopic ultrasound-guided fine needle aspiration (EUS-B-FNA) for the respiratory failure patients with lung cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic yeild and safety of EUS-B-FNA.
Key secondary outcomes
Ratio of evaluable samples by the PD-L1 immunohistochemistry.
Ratio of evaluable samples of oncogene mutation status (EGFR, ROS1, ALK, and BRAF).
Overall survival.
Overall survival stratified by existence of driver oncogene or tumor PD-L1 expression.
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
1. The patients with suspicion of lung cacner on radiological examinations.
2. Patiants who have a lesion adjacent to esophagus which is accessible by EUS-B-FNA.
3. Patients who need oxygen therapy to maintain oxygen saturation (90%), whose condition make it impossible or difficult to perform bronchoscopy because of respiratory comorbidity, or who have poor ECOG-PS (2 or more).
Key exclusion criteria
1. Patients with esophageal varices or coagulation disorder.
2. Pregnant woman.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yukihiro |
| Middle name | |
| Last name | Umeda |
Organization
University of Fukui
Division name
Third department of internal medicine
Zip code
910-1193
Address
23-3, Matsuokashimoaizuki, Eiheiji-cho, Fukui, Japan
TEL
0776-61-3111
umeda@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Yukihiro |
| Middle name | |
| Last name | Umeda |
Organization
University of Fukui
Division name
Third department of internal medicine
Zip code
910-1193
Address
23-3, Matsuokashimoaizuki, Eiheiji-cho, Fukui, Japan
TEL
0776613111
Homepage URL
umeda@u-fukui.ac.jp
Sponsor or person
Institute
Third department of internal medicine, Universtiy of Fukui
Institute
Department
Personal name
Funding Source
Organization
Third department of internal medicine, Universtiy of Fukui
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, Fukui, Japan
Tel
0776-61-3111
smsien-k@ad.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
福井大学医学部附属病院（福井県）、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
| 2020 | Year | 07 | Month | 28 | 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
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 28 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study.
Management information
Registered date
| 2020 | Year | 07 | Month | 28 | Day |
Last modified on
| 2023 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047088
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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