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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000020394
Receipt No. 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

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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
Email 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
Email fukukats@luke.ac.jp

Sponsor
Institute St. Luke's International Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023551

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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