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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023213
Receipt No. 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 2018/02/08

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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
Middle name
Last name Satoshi Tanno
Organization IMS Sapporo Digestive Disease Center General Hospital
Division name Department of Gastroenterology
Zip code
Address 1-1-1, Hachiken-nijou-nishi, Nishi-ku, Sapporo
TEL 011-611-1391
Email satoshtanno@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Tanno
Organization IMS Sapporo Digestive Disease Center General Hospital
Division name Department of Gastroenterology
Zip code
Address 1-1-1, Hachiken-nijou-nishi, Nishi-ku, Sapporo
TEL 011-611-1391
Homepage URL
Email satoshtanno@gmail.com

Sponsor
Institute Japan Pancreas Society
Institute
Department

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
Address
Tel
Email

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
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
2016 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
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
2018 Year 02 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026620

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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