UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002934 |
|---|---|
| Receipt number | R000003569 |
| Scientific Title | The Impact of Colon Lesion Detection Using Narrow Band Imaging: A Randomized Controlled Trial by Modified Back-to-Back Colonoscopy |
| Date of disclosure of the study information | 2010/01/01 |
| Last modified on | 2012/06/25 18:52:47 |
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Basic information
Public title
The Impact of Colon Lesion Detection Using Narrow Band Imaging: A Randomized Controlled Trial by Modified Back-to-Back Colonoscopy
Acronym
Colon NBI study
Scientific Title
The Impact of Colon Lesion Detection Using Narrow Band Imaging: A Randomized Controlled Trial by Modified Back-to-Back Colonoscopy
Scientific Title:Acronym
Colon NBI study
Region
| Japan |
Condition
Condition
the patient from 20 to 80 years old to perform colonoscopic examination
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the detection rate of the lesion at the time of the observation in the first time in the right colon 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 detection rate of the colon lesion at the time of the observation in the first time.
Key secondary outcomes
The miss rate of the colon lesion using either white light or narrow band imaging.
The differentiation ability of neoplastic and non-neoplastic lesion.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
the first NBI observation and second white light observation
Interventions/Control_2
the first white light observation and second NBI observation
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
| 80 | years-old | > |
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
800
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Ikematsu |
Organization
National Cancer Center Hospital East
Division name
Digestive Endoscopy
Zip code
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL
04-7133-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Ikematsu |
Organization
National Cancer Center Hospital East
Division name
Digestive Endoscopy
Zip code
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL
04-7133-1111
Homepage URL
hikemats@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
health and labour sciences research grants
Organization
Division
Category of Funding Organization
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
岡山大学病院（岡山県）、京都大学病院（京都府）、国立がんセンター中央病院（東京都）
国立がんセンター東病院（千葉県）、佐野病院（兵庫県）、広島大学病院（広島県）、京都府立医科大学病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2008 | Year | 05 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 12 | Month | 24 | Day |
Last modified on
| 2012 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003569
| 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 |
