UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014555 |
|---|---|
| Receipt number | R000016934 |
| Scientific Title | Detectability of colorectal polyp using the novel endoscopic system which a laser light source was equipped with: a multicenter randomized controlled trial |
| Date of disclosure of the study information | 2014/07/15 |
| Last modified on | 2018/01/15 16:42:56 |
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Basic information
Public title
Detectability of colorectal polyp using the novel endoscopic system which a laser light source was equipped with: a multicenter randomized controlled trial
Acronym
BLI STUDY
Scientific Title
Detectability of colorectal polyp using the novel endoscopic system which a laser light source was equipped with: a multicenter randomized controlled trial
Scientific Title:Acronym
BLI STUDY
Region
| Japan |
Condition
Condition
colorectal lesion
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare detectability of colorectal polyp using the novel endoscopic system of a laser light source with conventional endoscopic system of the xenon lamp.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The numbers of detected colorectal adenomatous lesions
Key secondary outcomes
The numbers of detected colorectal any lesions
Observation time
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
Endoscopic system of the laser light source
(blue laser imaging observation)
Interventions/Control_2
Endoscopic system of the xenon light source
(white light imaging 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
| 40 | 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
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Ikematsu |
Organization
National Cancer Center Hospital East
Division name
Department of Gastroenterology & Gastrointestinal Oncology
Zip code
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL
04-7133-1111
hikemats@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Ikematsu |
Organization
National Cancer Center Hospital East
Division name
Department of Gastroenterology & Gastrointestinal Oncology
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
No
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
京都府立医科大学病院（京都府）、国立がん研究センター中央病院（東京都）、国立がん研究センター東病院（千葉県）、自治医科大学付属病院（栃木県）、地域医療機能推進機構 群馬中央病院（群馬県）、東京慈恵会医科大学葛飾医療センター（東京都）、福岡大学筑紫病院（福岡県）、福島県立医科大学会津医療センター（福島県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 15 | 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
Main results already published
Date of protocol fixation
| 2014 | Year | 06 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2015 | Year | 08 | Month | 07 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 14 | Day |
Last modified on
| 2018 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016934
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2015/08/07 | 150807UMIN登録データBLI.xlsx |
