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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000047666
Receipt No. R000054349
Scientific Title Clinical performance of computer-aided detection of colorectal neoplasia using artificial intelligence
Date of disclosure of the study information 2022/05/06
Last modified on 2022/05/06

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Basic information
Public title Veridation research of colonoscopy using artificial intelligence
Acronym Veridation research of colonoscopy using artificial intelligence
Scientific Title Clinical performance of computer-aided detection of colorectal neoplasia using artificial intelligence
Scientific Title:Acronym Clinical performance of computer-aided detection of colorectal neoplasia using artificial intelligence
Region
Japan

Condition
Condition colo-rectal adenoma or cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of adenoma detection rate by colonoscopy using artificial intelligence
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Adenoma detection rate in total colonoscopy
Key secondary outcomes Adenoma miss rate in recto-sigmoid scopy

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 colonoscopy with/without AI (computer-aided detection)
Interventions/Control_2 colonoscopy without AI (computer-aided detection)
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
33 years-old <=
Age-upper limit
74 years-old >=
Gender Male and Female
Key inclusion criteria Colorectal cancer screening endoscopy, colonoscopy after fecal occult blood positive test, surveillance after colorectal polyp resection
Key exclusion criteria After colorectal surgery
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Hirotaka
Middle name
Last name Nakashima
Organization Foundation for detection of early gastric carcinoma
Division name depatment of gastroenterology
Zip code 103-0025
Address 2-6-12, Nihombashikayabacho, Chuo Ward, Tokyo
TEL 03-3668-6803
Email nakashima@soiken.or.jp

Public contact
Name of contact person
1st name Hirotaka
Middle name
Last name Nakashima
Organization Foundation for detection of early gastric carcinoma
Division name depatment of gastroenterology
Zip code 103-0025
Address 2-6-12, Nihombashikayabacho, Chuo Ward, Tokyo
TEL 03-3668-6803
Homepage URL
Email nakashima@soiken.or.jp

Sponsor
Institute Foundation for detection of early gastric carcinoma
Institute
Department

Funding Source
Organization FUJIFILM Corporation
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 Foundation for detection of early gastric carcinoma
Address 2-6-12, Nihombashikayabacho, Chuo Ward,Tokyo
Tel 03-3668-6803
Email nakashima@soiken.or.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

Other administrative information
Date of disclosure of the study information
2022 Year 05 Month 06 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 400
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
2020 Year 12 Month 28 Day
Date of IRB
2020 Year 11 Month 19 Day
Anticipated trial start date
2021 Year 01 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 05 Month 06 Day
Last modified on
2022 Year 05 Month 06 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054349

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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