UMIN-CTR Clinical Trial

Basic information
Public title	Peripheral leukocyte function as a predictive marker of endoscopic activity and efficacy of apheresis in patients with ulcerative colitis
Acronym	Peripheral leukocyte function in patients with ulcerative colitis
Scientific Title	Peripheral leukocyte function as a predictive marker of endoscopic activity and efficacy of apheresis in patients with ulcerative colitis
Scientific Title:Acronym	Peripheral leukocyte function in patients with ulcerative colitis
Region	Japan

Condition
Condition	Ulcerative colitis
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the predictive power of peripheral leukocyte function for therapeutic effect of granulocyte and monocyte adsorptive apheresis in patients with ulcerative colitis.
Basic objectives2	Others
Basic objectives -Others	To clarify the predictive power
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The relationship between peripheral leukocyte function and efficacy of granulocyte and monocyte adsorptive apheresi
Key secondary outcomes	The relationship between peripheral leukocyte function and endoscopic activity

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	16 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	1. The relationship between peripheral leukocyte function and endoscopic activity: Remission stage (n=20), Active stage (n=20) 2. The relationship between peripheral leukocyte function and effect of granulocyte and monocyte adsorptive apheresis: Active stage (>=CAI 7) patients who were treated with granulocyte and monocyte adsorptive apheresis (n=30) or tacrolimus (n=10)
Key exclusion criteria	Patients with known renal dysfunction, severe hepatic dysfunction or malignancy, and pregnant women were excluded, ect.
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Middle name Last name Sakiko Hiraoka
Organization	Okayama University Hospital
Division name	Department of Gastroenterology
Zip code
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
TEL	086-235-7219
Email	sakikoh@cc.okayama-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Toshihiro Inokuchi
Organization	Okayama University Hospital
Division name	Department of Gastroenterology
Zip code
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
TEL	086-235-7219
Homepage URL
Email	sakikoh@cc.okayama-u.ac.jp

Sponsor
Institute	Okayama University Hospital
Institute
Department

Funding Source
Organization	JIMRO Company , Limited
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Okayama Saiseikai General Hospital Tsuyama Central Hospital Kurashiki Central Hospital Wakayama Medical University
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	2012 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	Completed
Date of protocol fixation	2012 Year 07 Month 12 Day
Date of IRB	2012 Year 07 Month 24 Day
Anticipated trial start date	2012 Year 08 Month 01 Day
Last follow-up date	2016 Year 07 Month 31 Day
Date of closure to data entry	2016 Year 07 Month 31 Day
Date trial data considered complete	2017 Year 03 Month 31 Day
Date analysis concluded	2018 Year 04 Month 01 Day

Other
Other related information	no findings

Management information
Registered date	2012 Year 07 Month 16 Day
Last modified on	2021 Year 05 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009939