UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046169 |
|---|---|
| Receipt number | 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 | 2022/01/29 18:30:37 |
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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
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
mgonda@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052698
