UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060148 |
|---|---|
| Receipt number | R000067995 |
| Scientific Title | Prospective cohort study of the characteristics and outcomes of pancreatic diseases (including fatty pancreas, pancreatic cysts, asymptomatic morphological changes of the pancreas, and asymptomatic pancreatic enzyme elevation) |
| Date of disclosure of the study information | 2026/01/01 |
| Last modified on | 2025/12/21 06:02:26 |
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Basic information
Public title
Research on the characteristics and outcomes of pancreatic diseases
Acronym
Research on pancreatic diseases
Scientific Title
Prospective cohort study of the characteristics and outcomes of pancreatic diseases (including fatty pancreas, pancreatic cysts, asymptomatic morphological changes of the pancreas, and asymptomatic pancreatic enzyme elevation)
Scientific Title:Acronym
Prospective cohort study of pancreatic diseases
Region
| Japan |
Condition
Condition
Pancreatic diseases (including fatty pancreas, pancreatic cysts, asymptomatic morphological changes of the pancreas, and asymptomatic pancreatic enzyme elevation)
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the characteristics of and outcomes of pancreatic diseases
Basic objectives2
Others
Basic objectives -Others
Participant factors include demographics (e.g., age, sex, lifestyle, current medical history, family history, past medical history, medications, and anthropometric factors), laboratory tests, imaging tests, and endoscopic findings.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Cross-sectional analysis: pancreatic diseases and participant factors
Longitudinal analyisis 1: pancreatic diseases and long-term outocmes (e.g., the changes in the index pancreatic diseases and the incidences of pancreatic cancer and diabetes mellitus)
Longitudinal analyisis 2: participant factors and long-term incidence of pancreatic diseases
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals who undergo a health checkup during the study period
Key exclusion criteria
Participants with missing data on the main exposure variable of a given analysis
Target sample size
100000
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Hamada |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Gastroenterology
Zip code
1138655
Address
7-3-1 Hongo, Bunkyo City, Tokyo
TEL
03-3815-5411
hamada-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Oyama |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Gastroenterology
Zip code
1138655
Address
7-3-1 Hongo, Bunkyo City, Tokyo
TEL
03-3815-5411
Homepage URL
hooyama-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Tsuyoshi Hamada
Funding Source
Organization
None.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee of The University of Tokyo
Address
7-3-1 Hongo, Bunkyo City, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.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
東京大学医学部附属病院（東京都）、社会医療法人財団石心会 アルファメディック・クリニック（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | 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
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
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2031 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2031 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2031 | Year | 12 | Month | 31 | Day |
Other
Other related information
The data of medical check-up participants in the institutions of this study (The University of Tokyo Hospital and Alpha Medic Clinic) are collected and analyzed.
Management information
Registered date
| 2025 | Year | 12 | Month | 21 | Day |
Last modified on
| 2025 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067995
