UMIN-CTR Clinical Trial

Basic information
Public title	A study on the classification of inflammatory bowel disease by the patterns of immunological profiles
Acronym	Classification of inflammatory bowel disease by the patterns of immunological profiles
Scientific Title	A study on the classification of inflammatory bowel disease by the patterns of immunological profiles
Scientific Title:Acronym	Classification of inflammatory bowel disease by the patterns of immunological profiles
Region	Japan

Condition
Condition	Crohn's Disease, ulcerative colitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this study, the array of immunological makers, such as cytokines and chemokines, will be measured in the intestinal tissue and the serum samples of patients with inflammatory bowel disease (ulcerative colitis and Crohn's disease) and healthy volunteers to test if those diseases can be categorized into subgroups by the patterns of immunological skewing.
Basic objectives2	Others
Basic objectives -Others	1. Classification of inflammatory bowel disease by the patterns of immunological profiles. 2. The feasibility of the immunological classification of inflammatory bowel disease for the selection of proper therapeutic strategy.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The immunological profiling will be determined by the measurement of cytokines, chemokines and other factors in the serum and intestinal tissue samples. The patients will be classified into subgroups by the immunological features, and the correlation of endoscopical disease activity, clinical course, and the responsiveness and/or resistance to therapy protocol with those subgroups will be analyzed.
Key secondary outcomes	The feasibility of immunological profiling for the selection of proper therapeutic strategy and prediction of the clinical course.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Maneuver
Interventions/Control_1	5 ml of blood sample and 3 biopsy samples of the intestinal tissue will be collected from each person.
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with inflammatory bowel disease and healthy volunteers.
Key exclusion criteria	[Patients] Pregnant women are excluded. Patients who have obvious intestinal disease and/or systemic inflammation caused by other than inflammatory bowel disease, such as advanced cancer, systemic autoimmune disease, and infections are excluded. Patients with bleeding tendency are excluded. [Healthy volunteers] Pregnant women are excluded. Persons with bleeding tendency are excluded.
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Middle name Last name Namiko Hoshi
Organization	Kobe University Graduate School of Medicine
Division name	Gastroenterology
Zip code
Address	7-5-1 Kusunoki, Chuo-Ward, Kobe, Japan
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Namiko Hoshi
Organization	Kobe University Graduate School of Medicine
Division name	Gastroenterology
Zip code
Address
TEL	078-382-5774
Homepage URL
Email

Sponsor
Institute	Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	MEXT(Japan)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

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	2013 Year 07 Month 04 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	Terminated
Date of protocol fixation	2013 Year 06 Month 11 Day
Date of IRB	2013 Year 06 Month 11 Day
Anticipated trial start date	2013 Year 06 Month 12 Day
Last follow-up date	2019 Year 01 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 07 Month 04 Day
Last modified on	2020 Year 07 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013020