UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029979 |
|---|---|
| Receipt number | R000034239 |
| Scientific Title | Evaluation of pancreatic exocrine function using fecal elastase test among dijestive disease patients. |
| Date of disclosure of the study information | 2017/12/01 |
| Last modified on | 2022/11/20 14:51:26 |
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Basic information
Public title
Evaluation of pancreatic exocrine function using fecal elastase test among dijestive disease patients.
Acronym
Evaluation of pancreatic exocrine function using fecal elastase test among dijestive disease patients.
Scientific Title
Evaluation of pancreatic exocrine function using fecal elastase test among dijestive disease patients.
Scientific Title:Acronym
Evaluation of pancreatic exocrine function using fecal elastase test among dijestive disease patients.
Region
| Japan |
Condition
Condition
Dijestive disease
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify pancreatic exocrine function in digestive disease cases.
Basic objectives2
Others
Basic objectives -Others
To clarify pancreatic exocrine function among
each digestive diseases and it's sequential change.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pancreatic exocrine function
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
People with digestive disorder cases and healthy volunteers who understand the examination contents and obtain consent to the examination.
Key exclusion criteria
People who do not accept the examination.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Watanabe |
Organization
Shinshu University
Division name
Department of Gastroenterology
Zip code
3908621
Address
3-1-1, Asahi, Matsumoto City, Nagano Prefecture
TEL
09044780592
wat1400@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Watanabe |
Organization
Shinshu University
Division name
Department of Gastroenterology
Zip code
3908621
Address
3-1-1, Asahi, Matsumoto City, Nagano Prefecture
TEL
09044780592
Homepage URL
wat1400@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited
Takeda reserch support
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
Shinshu University Ethics Committee
Address
3-1-1, Asahi, Matsumoto City, Nagano Prefecture
Tel
0263-37-2572
mdrinri@shinshu-u.ac.jp
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
| 2017 | Year | 12 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational research; We assess pancreatic exocrine function of dijestive disease patients using fecal elastase. And if possible, we assess regulary after first examination.
Management information
Registered date
| 2017 | Year | 11 | Month | 15 | Day |
Last modified on
| 2022 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034239
