UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003373 |
|---|---|
| Receipt number | R000003915 |
| Scientific Title | Lymphocyte subsets in the peripheral blood of patients with pancreatic and biliary diseases |
| Date of disclosure of the study information | 2010/03/25 |
| Last modified on | 2012/09/07 11:26:57 |
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Basic information
Public title
Lymphocyte subsets in the peripheral blood of patients with pancreatic and biliary diseases
Acronym
Lymphocyte subsets in the peripheral blood of patients with pancreatic and biliary diseases
Scientific Title
Lymphocyte subsets in the peripheral blood of patients with pancreatic and biliary diseases
Scientific Title:Acronym
Lymphocyte subsets in the peripheral blood of patients with pancreatic and biliary diseases
Region
| Japan |
Condition
Condition
Pancreatic and biliary diseases
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to develop the new diagnosis and treatment for pancreatic and biliary diseases. This study is planned to examine the immunopathological roles in pancreatic and biliary diseases, especially the lymphocyte subsets.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lymphocyte subsets
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
Diagnosed as pancreatic and biliary diseases, such as the pancreatic carcinoma, the carcinoma of the biliary tract, the acute pancreatitis, or the cholangitis, which is diagnosed by images or the tissue samples
Key exclusion criteria
Minor
Lymphocyte < 1000/microL
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takanori Kanai |
Organization
School of Medicine, Keio University
Division name
Dep Internal Medicine, Div. Gastroenterology
Zip code
Address
Shinanomachi 35, Shinjyuku-ku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
School of Medicine, Keio University
Division name
Dep Internal Medicine, Div. Gastroenterology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
School of Medicine, Keio University
Dep Internal Medicine, Div. Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
School of Medicine, Keio University
Div. Gastroenterology, Dep Internal Medicine
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 | 03 | Month | 25 | 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
Completed
Date of protocol fixation
| 2010 | Year | 02 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 01 | Day |
Other
Other related information
observation
Management information
Registered date
| 2010 | Year | 03 | Month | 24 | Day |
Last modified on
| 2012 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003915
