UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004191 |
|---|---|
| Receipt number | R000004856 |
| Scientific Title | Prospective study for branch duct intraductal papillary mucinous neoplasms |
| Date of disclosure of the study information | 2010/10/01 |
| Last modified on | 2012/04/19 23:01:46 |
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Basic information
Public title
Prospective study for branch duct intraductal papillary mucinous neoplasms
Acronym
Prospective study forBD-IPMNs
Scientific Title
Prospective study for branch duct intraductal papillary mucinous neoplasms
Scientific Title:Acronym
Prospective study forBD-IPMNs
Region
| Japan |
Condition
Condition
Intraductal papillary mucinous neoplasm(IPMN)
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Natural history of BD-IPMN
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Rate of progression
Key secondary outcomes
Presence of new IPMN lesions, pancreatic cancers, extrapancreatic malignancies. How to progress BD-IPMNs
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
1: diagnosed of BD-IPMN
2: diameter of MPD <10mm and height of mural nodule <5mm
3: any age and both sex is OK
4: Receive informed consent
Key exclusion criteria
1: No informed consent
2: diameter of MPD ≥10mm and/or height of mural nodule ≥5mm
3: allergy for contrast
4: don't perform MRI
5: doctors judgement is not appropriate for this study
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsutomu Chiba |
Organization
Kyoto University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL
075-751-4319
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuzo Kodama |
Organization
Kyoto University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL
075-751-4319
Homepage URL
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2010 | Year | 10 | Month | 01 | 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
| 2010 | Year | 09 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 04 | Month | 01 | Day |
Other
Other related information
To identify the natural history of BD-IPMN, we'll perform long time follow up.
Management information
Registered date
| 2010 | Year | 09 | Month | 10 | Day |
Last modified on
| 2012 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004856
