UMIN-CTR Clinical Trial

Basic information
Public title	Investigate cell functions after sorting of antigen-specific peripheral blood and gastrointestinal mucosal lymphocytes in patients with inflammatory bowel disease
Acronym	Investigate cell functions after sorting of antigen-specific peripheral blood and gastrointestinal mucosal lymphocytes in patients with inflammatory bowel disease
Scientific Title	Investigate cell functions after sorting of antigen-specific peripheral blood and gastrointestinal mucosal lymphocytes in patients with inflammatory bowel disease
Scientific Title:Acronym	Investigate cell functions after sorting of antigen-specific peripheral blood and gastrointestinal mucosal lymphocytes in patients with inflammatory bowel disease
Region	Japan

Condition
Condition	inflammatory bowel disease
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We use peripheral blood and intestinal mucosa of patients with inflammatory bowel disease in this study. A fraction of T lymphocytes is sorted using a specific surface antigen. We investigate the function and properties of the specific cell population.
Basic objectives2	Others
Basic objectives -Others	pathophysiology
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To investigate the function and properties of the specific cell population
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	20 years-old <=
Age-upper limit	99 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with inflammatory bowel disease
Key exclusion criteria	Women who are pregnant or may be pregnant
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Masaya Middle name Last name Iwamuro
Organization	Okayama University Hospital
Division name	Department of Gastroenterology and Hepatology
Zip code	700-8558
Address	2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558
TEL	0862357218
Email	iwamuromasaya@yahoo.co.jp

Public contact
Name of contact person	1st name Masaya Middle name Last name Iwamuro
Organization	Okayama University Hospital
Division name	Department of Gastroenterology and Hepatology
Zip code	700-8558
Address	2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558
TEL	0862357218
Homepage URL
Email	iwamuromasaya@yahoo.co.jp

Sponsor
Institute	Okayama University Hospital
Institute
Department

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)

IRB Contact (For public release)
Organization	Okayama University IRB
Address	2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558
Tel	0862357218
Email	iwamuromasaya@yahoo.co.jp

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	2022 Year 06 Month 02 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	Open public recruiting
Date of protocol fixation	2022 Year 05 Month 27 Day
Date of IRB	2022 Year 05 Month 27 Day
Anticipated trial start date	2022 Year 06 Month 02 Day
Last follow-up date	2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We use peripheral blood and intestinal mucosa of patients with inflammatory bowel disease in this study. A fraction of T lymphocytes is sorted using a specific surface antigen. We investigate the function and properties of the specific cell population.

Management information
Registered date	2022 Year 06 Month 02 Day
Last modified on	2022 Year 06 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054640