UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021474 |
|---|---|
| Receipt number | R000024762 |
| Scientific Title | Analysis of a factor associated with a Lymph node metastasis in the operation case of Intraductal Papillary Mucinous Neoplasm of Pancreas |
| Date of disclosure of the study information | 2016/05/14 |
| Last modified on | 2017/02/22 13:41:27 |
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Basic information
Public title
Analysis of a factor associated with a Lymph node metastasis in the operation case of Intraductal Papillary Mucinous Neoplasm of Pancreas
Acronym
Analysis of a factor associated with a Lymph node metastasis in the operation case IPMN
Scientific Title
Analysis of a factor associated with a Lymph node metastasis in the operation case of Intraductal Papillary Mucinous Neoplasm of Pancreas
Scientific Title:Acronym
Analysis of a factor associated with a Lymph node metastasis in the operation case IPMN
Region
| Japan |
Condition
Condition
Invasive Intraductal Papillary Mucinous Neoplasm of Pancreas
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To find the factors associated with lymph node metastasis of Invasive IPMN
Basic objectives2
Others
Basic objectives -Others
To find the factors associated with lymph node metastasis of Invasive IPMN
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To analyze the association between patient's background characteristics and lymph node metastasis of Invasive IPMN using chi-square test
Key secondary outcomes
1.For factors which are significant by chi-square test, we will conduct multivariate logistic regression analysis.
2.For factors which are significant by chi-square test, we will conduct Kaplan-Meier estimation.
Significance level will be evaluated by the log-rank test.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Invasive Intraductal Papillary Mucinous Neoplasm of Pancreas which was operated by kobe University Hospital between June 2000 to August 2015
Key exclusion criteria
The patient which was complicated by other cancer
Target sample size
47
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsuhiro Masuda |
Organization
Kobe University Graduate School of Medicine
Division name
Gastroenterology
Zip code
Address
a7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL
078-382-6305
atmasuda@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kodai Yamanaka |
Organization
Kobe University Graduate School of Medicine
Division name
Gastroenterology
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan, 650-0017
TEL
078-382-6305
Homepage URL
Yamakou@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kobe University 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
Address
Tel
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 | 05 | Month | 14 | 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
Main results already published
Date of protocol fixation
| 2016 | Year | 03 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 14 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design
Retrospective observational study
Subjects
Invasive Intraductal Papillary Mucinous Neoplasm of Pancreas which was operated by kobe University Hospital between June 2000 to August 2015
Management information
Registered date
| 2016 | Year | 03 | Month | 15 | Day |
Last modified on
| 2017 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024762
