UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008448 |
|---|---|
| Receipt number | R000009939 |
| Scientific Title | Peripheral leukocyte function as a predictive marker of endoscopic activity and efficacy of apheresis in patients with ulcerative colitis |
| Date of disclosure of the study information | 2012/08/01 |
| Last modified on | 2021/05/08 16:59:28 |
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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
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
sakikoh@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009939
