UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007150 |
|---|---|
| Receipt number | R000008304 |
| Scientific Title | The Impact of Colorectal Lesion Detection Using Narrow Band Imaging |
| Date of disclosure of the study information | 2012/02/01 |
| Last modified on | 2013/05/02 21:07:31 |
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Basic information
Public title
The Impact of Colorectal Lesion Detection Using Narrow Band Imaging
Acronym
Colon NBI study
Scientific Title
The Impact of Colorectal Lesion Detection Using Narrow Band Imaging
Scientific Title:Acronym
Colon NBI study
Region
| Japan |
Condition
Condition
colorectal polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the number of neoplastic lesion using either white light or narrow band imaging
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the number of neoplastic lesion using either white light or narrow band imaging
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
NBI observation
Interventions/Control_2
white light observation
Interventions/Control_3
NBI observation
Interventions/Control_4
white light observation
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
The patient to perform colonoscopy
Key exclusion criteria
IBD
FAP
HNPCC
A history of the colorectal surgery
Target sample size
380
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Horimatsu |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
Kawahara-cho, 54, Shogoin, Sakyo-ku, Kyoto
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
TEL
Homepage URL
thorimat@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
| 2012 | Year | 02 | Month | 01 | 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
| 2012 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 27 | Day |
Last modified on
| 2013 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008304
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
