UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009037 |
|---|---|
| Receipt number | R000010605 |
| Scientific Title | Evaluation of immune function for patients with bile duct cancer before and after chemotherapy |
| Date of disclosure of the study information | 2012/10/10 |
| Last modified on | 2012/10/03 21:39:55 |
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Basic information
Public title
Evaluation of immune function for patients with bile duct cancer before and after chemotherapy
Acronym
Evaluation of immune function for patients with bile duct cancer
Scientific Title
Evaluation of immune function for patients with bile duct cancer before and after chemotherapy
Scientific Title:Acronym
Evaluation of immune function for patients with bile duct cancer
Region
| Japan |
Condition
Condition
Bile duct cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of immune function before and after chemotherapy for patients with bile duct cancer
Basic objectives2
Others
Basic objectives -Others
Evaluation of immune function
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Measurement of T lymphocyte subset and lymphoproliferative capacity before and after chemotherapy
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
Bile duct cancer patients more than 20 year old who agreed to participate in this study
Key exclusion criteria
Bile duct cancer patients who did not agree to participate in this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Itaru Endo |
Organization
Graduate School of Medicine, Yokohama City University
Division name
Department of Gastroenterological Surgery
Zip code
Address
3-9, Fukuura, Kanazawa-ku, Yokohama 236-0004
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Graduate School of Medicine, Yokohama City University
Division name
Department of Gastroenterological Surgery
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Graduate School of Medicine, Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
undicided
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2012 | Year | 10 | Month | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluation of immunomodulation effect for patients with bile duct cancer who received chemotherapy
Management information
Registered date
| 2012 | Year | 10 | Month | 03 | Day |
Last modified on
| 2012 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010605
