UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Search about cytokine profile and clinical form in ulcerative colitis patient
Title of the study (Brief title)	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	Katsuyuyki Fukuda
Organization	St. Luke's International Hospital
Division name	Department of Gastroenterology
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	Katsuyuki Fukuda
Organization	St. Luke's International Hospital
Division name	Department of Gastroenterology
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2013 Year 08 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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