UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005718 |
|---|---|
| Receipt number | R000006759 |
| Scientific Title | Assessment of CXC chemokine receptor type 4 (CXCR4) expression as a predictive marker on the effect of leukocytapheresis for ulcerative colitis |
| Date of disclosure of the study information | 2011/06/06 |
| Last modified on | 2016/02/11 10:35:54 |
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Basic information
Public title
Assessment of CXC chemokine receptor type 4 (CXCR4) expression as a predictive marker on the effect of leukocytapheresis for ulcerative colitis
Acronym
Assessment of CXC chemokine receptor type 4 (CXCR4) expression as a predictive marker on the effect of leukocytapheresis for ulcerative colitis
Scientific Title
Assessment of CXC chemokine receptor type 4 (CXCR4) expression as a predictive marker on the effect of leukocytapheresis for ulcerative colitis
Scientific Title:Acronym
Assessment of CXC chemokine receptor type 4 (CXCR4) expression as a predictive marker on the effect of leukocytapheresis for ulcerative colitis
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate CXC chemokine receptor type 4 (CXCR4) expression as a predictive marker on the effect of leukocytapheresis for ulcerative colitis
Basic objectives2
Others
Basic objectives -Others
Clinical significance of measurement of CXCR4 expression on CD4 positive T cell as a predictive marker on the effect of leukocytapheresis
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
CXCR4 expression on CD4 positive T cell in peripheral blood
Key secondary outcomes
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
| Device,equipment |
Interventions/Control_1
Patients treated with leukocytapheresis (more than once per week, total 10 sessions) therapy have a regular blood test
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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with moderate, severe or intractable ulcerative colitis
2) Patients with ulcerative colitis of left side colitis or pancolitis type
3) Patients whom immunomodulator doses are not changed for two months
4) Patients that steroid doses are not increased in quantity for one week
Key exclusion criteria
1) Patients with proctitis
2) Patients with either white blood cell count of less than 3,000/mm3, or hemoglobin level of less than 10g/dL, or platelet count of less than 100,000/mm3
3) Patients with fulminating active ulcerative colitis (massive bleeding, perforation, toxic megacolon)
4) Patients with serious infection or cardiovascular disease or liver disease or kidney disease or respiratory disease or metabolic disease neurologic disease
5) Patients with hypotension (less than maximal blood pressure 80mmHg)
6) Patients with allergic anamnesis or experience or the fear of allergic hypersensitivity reaction
7) Patients having received inhibitor of angiotensin converting enzyme
8) Patients who are pregnant or have the possibility of pregnancy
9) Patients who are younger than 12 years old or low weight
10) Patients determined to be inappropriate for this study by the investigators
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Nakase |
Organization
Kyoto University Hospital
Division name
Division of Endoscopic Medicine
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan
TEL
075-751-4319
hiropy_n@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Minoru Matsuura |
Organization
Kyoto University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan
TEL
075-751-4319
Homepage URL
minomats@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
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
京都大学医学部附属病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 06 | 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
Completed
Date of protocol fixation
| 2011 | Year | 05 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
| 2013 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 03 | Day |
Last modified on
| 2016 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006759
