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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032107
Receipt No. R000036087
Scientific Title Comparative trial of diagnositic ability for colorectal tumor of Narrow band imaging (NBI), Blue laser imaging (BLaI) and Blue light imaging (BLiI)
Date of disclosure of the study information 2018/04/04
Last modified on 2019/04/05

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Basic information
Public title Comparative trial of diagnositic ability for colorectal tumor of Narrow band imaging (NBI), Blue laser imaging (BLaI) and Blue light imaging (BLiI)
Acronym Comparative trial of diagnositic ability for colorectal tumor of NBI, BLaI and BLiI
Scientific Title Comparative trial of diagnositic ability for colorectal tumor of Narrow band imaging (NBI), Blue laser imaging (BLaI) and Blue light imaging (BLiI)
Scientific Title:Acronym Comparative trial of diagnositic ability for colorectal tumor of NBI, BLaI and BLiI
Region
Japan

Condition
Condition Colorectal tumor
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the ability of diagnosis of NBI, BLaI and BLiI for colorectal tumor
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Precise diagnosis rate of NBI, BLaI and BLiI for colorectal polyps
Key secondary outcomes Colorectal tumor is diagnosed to Type1,Type2,Type3 according to NICE(NBI International Colorectal Endoscopic)classification and to Type1,Type2A,Type2B,Type3 according to JNET(Japan NBI expert team)classification
(1)Sensitivity, secificity, PPV, NPV for non neoplastic and neoplastic tumor
(2)Sensitivity, secificity, PPV, NPV for SM deep invasion tumor and CIS, SM sligt invasion tumor

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Diagnose colorectal tumor with NBI(Narrow band imaging)
Interventions/Control_2 Diagnose colorectal tumor with BLaI(Blue laser imaging)
Interventions/Control_3 Diagnose colorectal tumor with BLiI(Blue light imaging)
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

Not applicable
Gender Male and Female
Key inclusion criteria Scheduled for endoscopic resection for colorectal tumor
Key exclusion criteria Patients judged inappropriate for the trial by investigators
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Takuma
Middle name
Last name Higurashi
Organization Yokohama City University
Division name Department of Gastroenterology and Hepatology
Zip code 236-0004
Address 3-9Fukuura, Kanazawa, Yokohama, Kanagawa
TEL 045-787-2640
Email takuma_h@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name Takuma
Middle name
Last name Higurashi
Organization Yokohama City University
Division name Department of Gastroenterology and Hepatology
Zip code 236-0004
Address 3-9Fukuura, Kanazawa, Yokohama, Kanagawa
TEL 045-787-2640
Homepage URL
Email takuma_h@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University
Institute
Department

Funding Source
Organization FUJI FILM
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Yokohama City University Hospital IRB
Address 3-9 Fukuura Kanazawa-ku Yokohama City
Tel 81-45-787-2640
Email takuma_h@yokohama-cu.ac.jp

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 横浜市立大学附属病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 04 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 Open public recruiting
Date of protocol fixation
2018 Year 04 Month 01 Day
Date of IRB
2018 Year 04 Month 02 Day
Anticipated trial start date
2018 Year 04 Month 04 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 04 Month 30 Day
Date trial data considered complete
2020 Year 05 Month 31 Day
Date analysis concluded
2020 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2018 Year 04 Month 04 Day
Last modified on
2019 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036087

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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