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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040907
Receipt No. R000046191
Scientific Title Risk Factors of Intraductal Papillary Mucinous Neoplasm of Pancreas in Health Screening Subjects
Date of disclosure of the study information 2020/06/30
Last modified on 2020/06/25

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Basic information
Public title Risk Factors of Intraductal Papillary Mucinous Neoplasm of Pancreas in Health Screening Subjects
Acronym Risk Factors of Intraductal Papillary Mucinous Neoplasm of Pancreas in Health Screening Subjects
Scientific Title Risk Factors of Intraductal Papillary Mucinous Neoplasm of Pancreas in Health Screening Subjects
Scientific Title:Acronym Risk Factors of Intraductal Papillary Mucinous Neoplasm of Pancreas in Health Screening Subjects
Region
Japan

Condition
Condition Intraductal Papillary Mucinous Neoplasm
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Percentage of pancreatic cysts and IPMN cases discovered after screening
Basic objectives2 Others
Basic objectives -Others Background Factors of IPMN Cases Discovered by Screening
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase

Assessment
Primary outcomes Percentage of IPMN found by screening
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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 15,859 healthy subjects underwent abdominal ultrasonography (US) between April 2012 and March 2013. In the cyst absent cases, those not achieving the complete image of whole pancreas were excluded. Finally, 9,363 subjects were included in this study. IPMN was defined as more than 5mm pancreatic cyst with the presence of communication to the main pancreatic duct or the presence of multilocular form. Multivariable logistic regression analysis was conducted to identify the risk factors of IPMN in comparison with the subjects without cysts, adjusted by clinical characteristics.
Key exclusion criteria ago
Target sample size 20000

Research contact person
Name of lead principal investigator
1st name Tsuyoshi
Middle name
Last name Fujita
Organization Yodogawa Christian Hospital
Division name Department of Gastroenterology
Zip code 533-0024
Address 1-7-50, Kunijima, Higashi Yodogawa Ku, Osaka, Japan
TEL 0120-364-489
Email tsuyofuji@gmail.com

Public contact
Name of contact person
1st name Tsuyoshi
Middle name
Last name Fujita
Organization Yodogawa Christian Hospital
Division name Department of Gastroenterology
Zip code 533-0024
Address 1-7-50, Kunijima, Higashi Yodogawa Ku, Osaka, Japan
TEL 0120-364-489
Homepage URL
Email tsuyofuji@gmail.com

Sponsor
Institute Yodogawa Christian Hospital
Institute
Department

Funding Source
Organization Yodogawa Christian Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board, Yodogawa Christian Hospital
Address 1-7-50, Kunijima, Higashi Yodogawa Ku, Osaka, Japan
Tel 0120-364-489
Email tsuyofuji@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
2020 Year 06 Month 30 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 15859
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 Completed
Date of protocol fixation
2012 Year 09 Month 01 Day
Date of IRB
2019 Year 09 Month 01 Day
Anticipated trial start date
2012 Year 09 Month 01 Day
Last follow-up date
2020 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 15,859 healthy subjects underwent abdominal ultrasonography (US) between April 2012 and March 2013. In the cyst absent cases, those not achieving the complete image of whole pancreas were excluded. Finally, 9,363 subjects were included in this study. IPMN was defined as more than 5mm pancreatic cyst with the presence of communication to the main pancreatic duct or the presence of multilocular form. Multivariable logistic regression analysis was conducted to identify the risk factors of IPMN in comparison with the subjects without cysts, adjusted by clinical characteristics.

Management information
Registered date
2020 Year 06 Month 25 Day
Last modified on
2020 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046191

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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