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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000037053
Receipt No. R000042207
Scientific Title Development of Computer-Aid Diagnosis System for T1b Colorectal Cancer on Non-magnified Plain Endoscopic Images: A Multicenter Study
Date of disclosure of the study information 2019/07/01
Last modified on 2020/08/10

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Basic information
Public title Development of AI Diagnosis System for T1b Colorectal Cancer on Non-magnified Plain Endoscopic Images
Acronym AI Dx for T1b CRC
Scientific Title Development of Computer-Aid Diagnosis System for T1b Colorectal Cancer on Non-magnified Plain Endoscopic Images: A Multicenter Study
Scientific Title:Acronym CAD for T1b CRC by Plain Images
Region
Japan

Condition
Condition Early stage colorectal cancer (Tis/T1a/T1b) receiving colonoscoppy between 2016 Jan. and 2018 Dec.
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To develop and evaluate Computer-aid Diagnosis System to differentiate Tis/T1a stage from T1b stage colorectal cancer.
Basic objectives2 Others
Basic objectives -Others Comparison with human endoscopists
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Specificity for T1b colorectal cancer
Key secondary outcomes Sensitivity, PPV, NPV and overall accuracy for T1b colorectal cancer

Base
Study type Others,meta-analysis etc

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 1) Consecutive series of Tis/T1a/T1b stage colorectal cancer endoscopically observed between 2016 Jan and 2018 December.
2) Non-magnified plain still images (3-5 shots)
Key exclusion criteria 1) Pedunculated morphology
2) Huge lesion, >5cm in size
3) Chromoendoscopic images
4) Images enhanced by NBI, BLI etc.
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name Kazutomo
Middle name
Last name Togashi
Organization Aizu Medical Center Fukushima Medical University
Division name Dept. of Coloproctology
Zip code 969-3492
Address 21-2Maeda, Tanisawa, Kawahigashi-machi, Aizuwakamatsu, Fukushima
TEL +81-242752100
Email togashik@fmu.ac.jp

Public contact
Name of contact person
1st name Masato
Middle name
Last name Aizawa
Organization Aizu Medical Center Fukushima Medical University
Division name Dept. of Coloproctology
Zip code 969-3492
Address 21-2Maeda, Tanisawa, Kawahigashi-machi, Aizuwakamatsu, Fukushima
TEL +81-242752100
Homepage URL
Email aizawa-m@fmu.ac.jp

Sponsor
Institute Fukushima Medical University
Institute
Department

Funding Source
Organization Fukushima Medical University
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 Fukushima Medical University
Address 1 Hikarigaoka, Fukushima-city
Tel +81-25471825
Email rs@@fmu.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 30301
Org. issuing International ID_1 Fukushima Medical University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 福島県立医科大学会津医療センター(福島県)、自治医科大学(栃木県)、群馬大学医学部(群馬県)、小樽掖済会病院(北海道)、佐賀大学医学部(佐賀県)、自治医科大学さいたま医療センター(埼玉県)、東京女子医科大学東医療センター(東京都)、岩手医科大学(岩手県)、東京女子医科大学消化器病センター(東京都)、京都府立医科大学(京都府)、会津大学コンピュータ理工学部(福島県)

Other administrative information
Date of disclosure of the study information
2019 Year 07 Month 01 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 1513
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2019 Year 04 Month 01 Day
Date of IRB
2019 Year 05 Month 24 Day
Anticipated trial start date
2019 Year 10 Month 01 Day
Last follow-up date
2020 Year 06 Month 30 Day
Date of closure to data entry
2020 Year 10 Month 31 Day
Date trial data considered complete
2020 Year 12 Month 31 Day
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information After deep learning, diagnostic performance of AI is measured in a new reading set. Also, human endoscopists read the same reading set, and the diagnostic performance is compared with AI.

Management information
Registered date
2019 Year 06 Month 13 Day
Last modified on
2020 Year 08 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042207

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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