UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031291 |
|---|---|
| Receipt number | R000035724 |
| Scientific Title | To assess the usefulness of new EBUS-TBNA needle. |
| Date of disclosure of the study information | 2018/02/20 |
| Last modified on | 2018/02/14 06:06:09 |
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Basic information
Public title
To assess the usefulness of new EBUS-TBNA needle.
Acronym
To assess the usefulness of new EBUS-TBNA needle.
Scientific Title
To assess the usefulness of new EBUS-TBNA needle.
Scientific Title:Acronym
To assess the usefulness of new EBUS-TBNA needle.
Region
| Japan |
Condition
Condition
Non-small cell lung cancer with advanced stage
Classification by specialty
| Medicine in general | Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of new EBUS-TBNA needle.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Yields of adequate tissue specimen sampling
Key secondary outcomes
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. Patients with enlarged mediastinal and/or hilar lesions 10 mm or greater in short-axis diameter on CT or FDG uptaken 2.5 or
higher in PET/CT imaging requiring diagnostic EBUS-TBNA
2. 20 years old and above
3. Informed consent
Key exclusion criteria
1.Patients requiring EBUS-TBNA for N-stage in patients with lung cancer
2.Serious concomitant medical illness
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Nakai |
Organization
National Cancer Center Hospital
Division name
Department of Endoscopy, Respiratory Endoscopy Division
Zip code
Address
5-1-1, Tukiji Chou-ku, Tokyo, Japan
TEL
03-3542-2511
tnakai@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Nakai |
Organization
National Cancer Center Hospital
Division name
Department of Endoscopy, Respiratory Endoscopy Division
Zip code
Address
5-1-1, Tukiji Chou-ku, Tokyo, Japan
TEL
03-3542-2511
Homepage URL
tnakai@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
The National Cancer Center Research and Development Fund
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2018 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 02 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The trial does not start.
Management information
Registered date
| 2018 | Year | 02 | Month | 14 | Day |
Last modified on
| 2018 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035724
