UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015088 |
|---|---|
| Receipt number | 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 | 2023/10/03 14:19:20 |
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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 | Yukihiro |
| Middle name | |
| Last name | Umeda |
Organization
University of Fukui
Division name
Third department of internal medicine
Zip code
9101193
Address
23-3, Matsuokashimoaizuki, Eiheiji-cho, Fukui, Japan
TEL
+81776613111
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
9101193
Address
23-3, Matsuokashimoaizuki, Eiheiji-cho, Fukui, Japan
TEL
+81776613111
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
Self founding
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
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
Terminated
Date of protocol fixation
| 2014 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 08 | Month | 04 | Day |
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
| 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=R000017306
