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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024747
Receipt No. R000028470
Scientific Title Endoscopic characterization of colorectal polyps by using blue laser imaging system: An international multi-center study
Date of disclosure of the study information 2016/11/08
Last modified on 2017/11/09

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Basic information
Public title Endoscopic characterization of colorectal polyps by using blue laser imaging system: An international multi-center study
Acronym Endoscopic characterization of colorectal polyps by using blue laser imaging system: An international multi-center study
Scientific Title Endoscopic characterization of colorectal polyps by using blue laser imaging system: An international multi-center study
Scientific Title:Acronym Endoscopic characterization of colorectal polyps by using blue laser imaging system: An international multi-center study
Region
Japan Asia(except Japan)

Condition
Condition Colorectal polyps
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To Evaluate the predictive validity and performance characteristics of the BLI system combined with the NICE and JNET classification systems for determination of polyp histology
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of performance to diagnose colorectal polyps by BLI
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
100 years-old >
Gender Male and Female
Key inclusion criteria The patients with colorectal polyps who received colonoscopy based on national insurance
Key exclusion criteria The patients who is judged as inappropriate by responsible doctor.
The patients who received chemotherapy or radiation therapy.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiki Hirooka
Organization Nagoya University Hospital
Division name Department of Endoscopy
Zip code
Address 65,Tsuruma-cho,Showa-ku,Nagoya-shi,Aichi
TEL 052-744-2601
Email hirooka@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Yamamura
Organization Nagoya University Hospital
Division name Department of Endoscopy
Zip code
Address 65,Tsuruma-cho,Showa-ku,Nagoya-shi,Aichi
TEL 052-744-2601
Homepage URL
Email tyamamu@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Hospital
Institute
Department

Funding Source
Organization Nagoya University Graduate School of Medicine,Gastroenterology and Hepatology
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
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

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 08 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 No longer recruiting
Date of protocol fixation
2016 Year 10 Month 31 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The aim of this study is to evaluate the predictive validity and performance characteristics of the BLI system combined with the classification systems for determination of polyp histology.

Management information
Registered date
2016 Year 11 Month 08 Day
Last modified on
2017 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028470

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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