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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002934
Receipt No. 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

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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
Email

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
Email hikemats@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003569

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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