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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014201
Receipt No. R000016517
Scientific Title Investigation of serum biomarker for prediction of efficacy of the treatments for inflammatory bowel disease
Date of disclosure of the study information 2014/06/06
Last modified on 2020/06/10

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Basic information
Public title Investigation of serum biomarker for prediction of efficacy of the treatments for inflammatory bowel disease
Acronym Biomarker for IBD
Scientific Title Investigation of serum biomarker for prediction of efficacy of the treatments for inflammatory bowel disease
Scientific Title:Acronym Biomarker for IBD
Region
Japan

Condition
Condition Inflammatory bowel diseases(ulcerative colitis, crohn's disease), intestinal Behcet disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effectiveness of oligosaccharide analysis of immunoglobulins and cytokines for the biomarkers for the efficacy of biologics in patients with inflammatory bowel diseases
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The titers of biomarkers(serum oligosaccharides in immunoglobulins and cytokines)
Key secondary outcomes

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

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patients with inflammatory bowel diseases(ulcerative colitis, Crohn's disease), Behcet disease
2)Patients who will use or are using biologics (infliximab and adalimumab)
Key exclusion criteria 1) Patients with mental diseases
2) Patients younger than 16 years old.
3) Patients who are not suitable to attend this study judged by physicians.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Hideki
Middle name
Last name Iijima
Organization Osaka University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code 565-0871
Address 2-15 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL +81-6-6879-3621
Email hiijima@gh.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Hideki
Middle name
Last name Iijima
Organization Osaka University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code 565-0871
Address 2-15 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL +81-6-6879-3621
Homepage URL
Email hiijima@gh.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Osaka University Graduate School of Medicine
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 Osaka University
Address 2-2 Yamadaoka, Suita, Osaka
Tel 06-6879-3621
Email hiijima@gh.med.osaka-u.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
2014 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 Open public recruiting
Date of protocol fixation
2014 Year 01 Month 01 Day
Date of IRB
2014 Year 05 Month 07 Day
Anticipated trial start date
2014 Year 06 Month 01 Day
Last follow-up date
2019 Year 06 Month 13 Day
Date of closure to data entry
2019 Year 06 Month 13 Day
Date trial data considered complete
2019 Year 06 Month 13 Day
Date analysis concluded
2019 Year 06 Month 13 Day

Other
Other related information Serum samples from the patients treated with biologics will be analyzed for biomarkers.

Management information
Registered date
2014 Year 06 Month 06 Day
Last modified on
2020 Year 06 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016517

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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