UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005032 |
|---|---|
| Receipt number | R000005987 |
| Scientific Title | Investigation of biomarkers for predicting effectiveness of treatments for inflammatory bowel diseases |
| Date of disclosure of the study information | 2011/03/01 |
| Last modified on | 2020/03/21 00:26:46 |
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Basic information
Public title
Investigation of biomarkers for predicting effectiveness of treatments for inflammatory bowel diseases
Acronym
Investigation of biomarkers for predicting effectiveness of treatments for inflammatory bowel diseases
Scientific Title
Investigation of biomarkers for predicting effectiveness of treatments for inflammatory bowel diseases
Scientific Title:Acronym
Investigation of biomarkers for predicting effectiveness of treatments for inflammatory bowel diseases
Region
| Japan |
Condition
Condition
inflammatory bowel diseases
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate biomarkers for predicting effectiveness of leukocyteapheresis, anti-TNF alpha antibody and tacrolimus for inflammatory bowel diseases
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate the several inflammatory substances to find out the usefullness biomarkers to predict the efficacy and prognosis of treatments in inflammatory bowel diseases
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
| Other |
Interventions/Control_1
to measure several inflammatory substances before and after the leukocyteapheresis, anti-TNF alpha antibody and tacrolimus for patients with inflammatory bowel diseases
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are applicable for the treatments of leukocyteapheresis, anti-TNF alpha antibody and tacrolimus
Patients who argee informed consent
Key exclusion criteria
Patients who are not applicable for the treatments of leukocyteapheresis, anti-TNF alpha antibody and tacrolimus
Patients who disargee informed consent
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Kato |
Organization
Saitama medical Center, Saitama medical University
Division name
Department of Gastroenterology and Hepatology
Zip code
350-8550
Address
1981 Kamoda, Kawagoe City, Saitama, Japan
TEL
049-228-3564
skato@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Kato |
Organization
Saitama medical Center, Saitama medical University
Division name
Department of Gastroenterology and Hepatology
Zip code
350-8550
Address
1981 Kamoda, Kawagoe City, Saitama, Japan
TEL
049-228-3564
Homepage URL
skato@saitama-med.ac.jp
Sponsor or person
Institute
Saitama medical Center, Saitama medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama medical Center, Saitama medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Saitama Medical Center
Address
1981 Kamoda, Kawagoe City, Saitama 3508550, Japan
Tel
049-228-3902
smcrinri@saitama-med.ac.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
| 2011 | Year | 03 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 05 | Day |
Last modified on
| 2020 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005987
