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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000046169
Receipt No. R000052698
Scientific Title Development of AI-based imaging system for early detection and diagnosis of pancreatic cancer
Date of disclosure of the study information 2021/11/24
Last modified on 2021/11/24

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Basic information
Public title Development of AI-based imaging system for early detection and diagnosis of pancreatic cancer
Acronym Development of AI-based imaging system for early detection and diagnosis of pancreatic cancer
Scientific Title Development of AI-based imaging system for early detection and diagnosis of pancreatic cancer
Scientific Title:Acronym Development of AI-based imaging system for early detection and diagnosis of pancreatic cancer
Region
Japan

Condition
Condition pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 In this study, we propose the following two goals to develop diagnostic imaging technology that can efficiently pick up suspicions of early-stage pancreatic cancer and introduce it into screening, and to establish a curable pancreatic cancer diagnostic system.
1. Development of AI-based imaging system for early detection of pancreatic cancer using non-contrast computed tomography
2. Feasibility study in several medical centers for the utility of AI-based imaging system for early detection of pancreatic cancer using non-contrast computed tomography
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Diagnosis accuracy of pancreatic cancer using AI-based imaging system
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients diagnosed with pancreatic cancer at Kobe University Hospital and the collaborating research institutions between January 1, 2014 and December 31, 2022
2. Patients diagnosed with non-pancreatic cancer at Kobe University Hospital and the collaborating research institutions between January 1, 2014 and December 31, 2022
Key exclusion criteria 1. Patients who expressed not to participate in the study
2. Patients who did not undergo abdominal CT scan
3. Patients who have a history of pancreatectomy
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name Yuzo
Middle name
Last name Kodama
Organization Kobe University Graduate School of Medicine
Division name Gastroenterology
Zip code 650-0017
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL 078-382-6305
Email kodama@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name Masanori
Middle name
Last name Gonda
Organization Kobe University Graduate School of Medicine
Division name Gastroenterology
Zip code 650-0017
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL 078-382-6305
Homepage URL
Email mgonda@med.kobe-u.ac.jp

Sponsor
Institute Kobe University
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 Division of Gastroenterology, Department of Internal Medicine Kobe University Graduate School of Medicine
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
Tel 078-382-6305
Email rinri@med.kobe-u.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 京都大学医学部附属病院(京都府)、近畿大学病院(大阪府)、和歌山県立医科大学附属病院(和歌山県)、兵庫医科大学病院(兵庫県)、明石医療センター(兵庫県)、高槻病院(大阪府)、千船病院(大阪府)、加古川中央市民病院(兵庫県)、日本生命病院(大阪府)、北播磨総合医療センター(兵庫県)、兵庫県立がんセンター(兵庫県)、神戸医療センター(兵庫県)、甲南医療センター(兵庫県)、公立宍粟総合病院(兵庫県)、製鉄記念広畑病院(兵庫県)、兵庫県立丹波医療センター(兵庫県)、兵庫県立淡路医療センター(兵庫県)、淀川キリスト教病院(兵庫県)、済生会中津病院(大阪府)、神戸赤十字病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2021 Year 11 Month 24 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
2020 Year 05 Month 25 Day
Date of IRB
2020 Year 05 Month 26 Day
Anticipated trial start date
2021 Year 07 Month 01 Day
Last follow-up date
2024 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2021 Year 11 Month 24 Day
Last modified on
2021 Year 11 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052698

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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