UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020394 |
|---|---|
| Receipt number | R000023551 |
| Scientific Title | Search about cytokine profile and clinical form in ulcerative colitis patient |
| Date of disclosure of the study information | 2016/01/01 |
| Last modified on | 2018/08/21 10:45:04 |
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Basic information
Public title
Search about cytokine profile and clinical form in ulcerative colitis patient
Acronym
Search about cytokine profile in ulcerative colitis patient(ExCyT Study)
Scientific Title
Search about cytokine profile and clinical form in ulcerative colitis patient
Scientific Title:Acronym
Search about cytokine profile in ulcerative colitis patient(ExCyT Study)
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To specify the subpopulation in ulcerative colitis
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement and evaluation of cytokine of TNF-alpha etc.
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
| 12 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects are selected only by ulcerative patient
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuyuyki Fukuda |
Organization
St. Luke's International Hospital
Division name
Department of Gastroenterology
Zip code
Address
9-1, Akashi-cho, Chuo-ku Tokyo 104-8560 Japan
TEL
03-3541-5151
fukukats@luke.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuyuki Fukuda |
Organization
St. Luke's International Hospital
Division name
Department of Gastroenterology
Zip code
Address
9-1, Akashi-cho, Chuo-ku Tokyo 104-8560 Japan
TEL
03-3541-5151
Homepage URL
fukukats@luke.ac.jp
Sponsor or person
Institute
St. Luke's International Hospital
Institute
Department
Personal name
Funding Source
Organization
Nothing particular
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
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 | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 08 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 08 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
case-control study
The patient who visited our hospital from August, 2013 to September, 2018
IL-6,TNF-alpha,etc.
Management information
Registered date
| 2015 | Year | 12 | Month | 29 | Day |
Last modified on
| 2018 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023551
