UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of clinical usefulness of serum biomarker for patients with IBD. And analyse correlations between efficacy of GMA and serum biomarker.
Title of the study (Brief title)	Correlations between efficacy of GMA and serum biomarker for patients with IBD.
Region	Japan

Condition
Condition	Ulcerative colitis Crohn's disease
Classification by specialty	Medicine in general Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to investigate of clinical usefulness of serum biomarker (MMP-9, etc.) for patients with IBD. And analyse correlations between efficacy of GMA and serum biomarker.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Clinical response rate. UC:Mayo score >= 30% decrease partial Mayo score >= 30% decrease CD:CDAI score >= 70 decrease
Key secondary outcomes	Clinical response rate. UC:Mayo score <= 2 partial Mayo score<= 2 CD:CDAI score<= 150

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	1:Patient who judged that GMA treatment was appropriate along guidelines on Ministry of Health, Labour and Welfare. 2:Patient who are older than 20 years old. 3:Patiens who agreed to precipitate in this study after being informed of the study protocol.
Key exclusion criteria	1:Patient with granulocytopenia (granulocyte count < 2,000/mm3). 2:Patient with or suspected to have severe infection. 3:Patient who judged to be exclusive by investigators for a certain reason.
Target sample size	15

Research contact person
Name of lead principal investigator	Taro Osada
Organization	Juntendo University
Division name	Department of Gastroenterology
Address	2-1-1 Hongo,Bunkyo,Tokyo,JapanTokyo Japan
TEL	03-3813-3111
Email	otaro@juntendo.ac.jp

Public contact
Name of contact person	Taro Osada
Organization	Juntendo University
Division name	Department of Gastroenterology
Address	2-1-1 Hongo,Bunkyo,Tokyo,JapanTokyo Japan
TEL	03-3813-3111
Homepage URL
Email	otaro@juntendo.ac.jp

Sponsor
Institute	Juntendo University
Institute
Department

Funding Source
Organization	JIMRO Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	The institute of medical science, the university of Tokyo
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 04 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 11 Month 01 Day
Anticipated trial start date	2016 Year 01 Month 04 Day
Last follow-up date	2017 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	We evaluate the correlations between efficacy of GMA and serum biomarker at before and after treatment. Design:cohort study This study is conducted to the patients matching inclusion criteria from Jan.2016 to Oct.2017.

Management information
Registered date	2015 Year 11 Month 19 Day
Last modified on	2016 Year 11 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022949