UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023213 |
|---|---|
| Receipt number | R000026620 |
| Scientific Title | A prospective multicenter cohort study in patients with pancreatic cysts less than 10 mm in size |
| Date of disclosure of the study information | 2016/07/19 |
| Last modified on | 2019/07/22 19:27:10 |
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Basic information
Public title
A prospective multicenter cohort study in patients with pancreatic cysts less than 10 mm in size
Acronym
A prospective multicenter cohort study in patients with pancreatic cysts less than 10 mm in size
Scientific Title
A prospective multicenter cohort study in patients with pancreatic cysts less than 10 mm in size
Scientific Title:Acronym
A prospective multicenter cohort study in patients with pancreatic cysts less than 10 mm in size
Region
| Japan |
Condition
Condition
Pancreatic cysts less than 10 mm in size
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The rate of occurrences of pancreatic ductal adenocarcinoma (PDAC)
Basic objectives2
Others
Basic objectives -Others
To elucidate the natural history of pancreatic cysts less than 10 mm in size
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The rate of occurrences of pancreatic ductal adenocarcinoma (PDAC)
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
Patients with pancreatic cysts less than 10 mm in size on MRI
Key exclusion criteria
1) Patients with pancreatic cysts 10 mm or more in size
2) Patients with pancreatic cysts less than 10 mm in size concomitant with pancreatic cysts 10 mm or more in size
3) A concurrence of pancreatic malignancies at the time of registration
5) Patients from whom informed consent cannot be obtained
6) Patients who are judged inappropriate for the participation for this study by attending doctors
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Tanno |
Organization
IMS Sapporo Digestive Disease Center General Hospital
Division name
Department of Gastroenterology
Zip code
063-0842
Address
1-1-1, Hachiken-nijou-nishi, Nishi-ku, Sapporo
TEL
011-611-1391
satoshtanno@gmail.com
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Tanno |
Organization
IMS Sapporo Digestive Disease Center General Hospital
Division name
Department of Gastroenterology
Zip code
063-0842
Address
1-1-1, Hachiken-nijou-nishi, Nishi-ku, Sapporo
TEL
011-611-1391
Homepage URL
satoshtanno@gmail.com
Sponsor or person
Institute
Japan Pancreas Society
Institute
Department
Personal name
Funding Source
Organization
Japan Pancreas Society
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
IMS Sapporo Digestive Disease Center General Hospital
Address
1-1-1, Hachiken-nijou-nishi, Nishi-ku, Sapporo
Tel
011-611-1391
satoshtanno@gmail.com
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 19 | 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
1131
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A multicenter prospective cohort study
Management information
Registered date
| 2016 | Year | 07 | Month | 18 | Day |
Last modified on
| 2019 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026620
