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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000015088
Receipt No. R000017306
Scientific Title Factors related to diagnostic yield of endobronchial ultrasound-guided transbronchial needle aspiration for nodal involvements in patients with lung cacncer
Date of disclosure of the study information 2014/09/10
Last modified on 2018/05/31

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Basic information
Public title Factors related to diagnostic yield of endobronchial ultrasound-guided transbronchial needle aspiration for nodal involvements in patients with lung cacncer
Acronym Factors related to diagnostic yield of endobronchial ultrasound-guided transbronchial needle aspiration in patients with lung cacncer
Scientific Title Factors related to diagnostic yield of endobronchial ultrasound-guided transbronchial needle aspiration for nodal involvements in patients with lung cacncer
Scientific Title:Acronym Factors related to diagnostic yield of endobronchial ultrasound-guided transbronchial needle aspiration in patients with lung cacncer
Region
Japan

Condition
Condition Primary lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 EBUS-TBNA is widely used for pathological diagnosis of lymph node metastasis of primary lung cancer. However, definite indication of EBUS-TBNA has not been showed in guideline. The aim of this study is to clarify definite indication of EBUS-TBNA.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To evaluate factors that predict the diagnostic yield of EBUS-TBNA, including chest CT and FDG-PET findings.
Key secondary outcomes Association of number of sequential biopsy specimens and diagnostic yield.
Association of lymph node location and diagnostic yield.
Complications.

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) Lung cancer patients with enlarged mediastinal or hilar lymph node with a short-axis diameter of 5mm or greater on CT.
2) Patients who underwent both chest CT and FDG-PET/CT 4 weeks before EBUS-TBNA procedure.
3) 20 years old or more.
Key exclusion criteria 1) Pregnant woman.
2) Fasting serum glucose levels above 126 mg/dl.
3) Severe complication.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukihiro Umeda
Organization University of Fukui
Division name Third department of internal medicine
Zip code
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
Middle name
Last name Yukihiro Umeda
Organization University of Fukui
Division name Third department of internal medicine
Zip code
Address 23-3, Matsuokashimoaizuki, Eiheiji-cho, Fukui, Japan
TEL 0776-61-3111
Homepage URL
Email umeda@u-fukui.ac.jp

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

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Fukui Red Cross Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 福井大学病院(福井県)、福井赤十字病院(福井県)

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 10 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 No longer recruiting
Date of protocol fixation
2014 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 10 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
2018 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information Prospective observational study.

Management information
Registered date
2014 Year 09 Month 08 Day
Last modified on
2018 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017306

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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