UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory research for markers of efficacy of treatment for inflammatory bowel disease
Title of the study (Brief title)	Exploratory research for markers of efficacy of treatment for IBD
Region	Japan

Condition
Condition	Crohn's disease Ulcerative colitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	The purpose of this study is to explore markers of efficacy in remission-induction therapy for Inflammatory Bowel Disease (IBD--including Crohn's Disease and Ulcerative Colitis) by analyzing blood, stool, and bowel tissue biopsy samples from IBD patients pre- and post-treatment.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	To show a correlation between therapeutic response of the remission-induction therapy and biomarkers.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with IBD before remission induction therapy(regardless of a prior treatment)
Key exclusion criteria	1. patients with a history of bowel resection(exclude appendectomy) 2. patients during pregnancy and lactation 3. patients who wish to become pregnant 4. patients who have an abdominal infection including an abdominal abscess 5. patients during chemotherapy and immunosuppressant therapy 6. patients with a history of a malicnant disease 7. patients who are ruled unfit to this study by doctors
Target sample size	230

Research contact person
Name of lead principal investigator	Takanori Kanai
Organization	Keio University Hospital
Division name	Gastroenterology
Address	35 Shinano-machi, Shinjuku-ku, Tokyo
TEL	03-5843-7090
Email	takagast@z2.keio.jp

Public contact
Name of contact person	Kosuke Yoshida
Organization	Keio university hospital
Division name	Gastroenterology
Address	35 Shinano-machi, Shinjuku-ku, Tokyo
TEL	03-5843-7090
Homepage URL
Email	borg768@keio.jp

Sponsor
Institute	Keio university hospital, Gastroenterology
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
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 08 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 07 Month 06 Day
Anticipated trial start date	2016 Year 08 Month 01 Day
Last follow-up date
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 explore markers of efficacy of the remission-induction therapy for inflammatory bowel diseases(IBD, including Crohn's disease and ulcerative colitis) by the analysis of samples(blood, stool, and biopsy form bowel tissue) taken from IBD patients before and after treatment.

Management information
Registered date	2016 Year 07 Month 23 Day
Last modified on	2016 Year 07 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026855