UMIN-CTR Clinical Trial

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	2022 Year 01 Month 29 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052698