UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041235
Receipt No. 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 2020/07/28

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email umeda@u-fukui.ac.jp

Sponsor
Institute Third department of internal medicine, Universtiy of Fukui
Institute
Department

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
Email 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 Open public recruiting
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
2020 Year 07 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047088

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.