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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000005032
Receipt No. 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 2019/03/24

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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
Middle name
Last name Shingo kato
Organization Saitama medical Center, Saitama medical University
Division name Department of Gastroenterology and Hepatology
Zip code
Address 1981 Kamoda, Kawagoe City, Saitama, Japan
TEL 049-228-3564
Email skato@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shingo Kato
Organization Saitama medical Center, Saitama medical University
Division name Department of Gastroenterology and Hepatology
Zip code
Address 1981 Kamoda, Kawagoe City, Saitama, Japan
TEL 049-228-3564
Homepage URL
Email skato@saitama-med.ac.jp

Sponsor
Institute Saitama medical Center, Saitama medical University
Institute
Department

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
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
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
2019 Year 03 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005987

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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