UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040907 |
|---|---|
| Receipt number | 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 23:28:10 |
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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
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
tsuyofuji@gmail.com
Sponsor or person
Institute
Yodogawa Christian Hospital
Institute
Department
Personal name
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
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
Value
https://center6.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 |
