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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017831
Receipt No. R000020655
Scientific Title Research for new biomarker about diagnosis and evaluation of disease condition for inflammatory bowel disease (IBD).
Date of disclosure of the study information 2015/08/01
Last modified on 2018/07/15

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Basic information
Public title Research for new biomarker about diagnosis and evaluation of disease condition for inflammatory bowel disease (IBD).
Acronym Research for new biomarker of inflammatory bowel disease (IBD)
Scientific Title Research for new biomarker about diagnosis and evaluation of disease condition for inflammatory bowel disease (IBD).
Scientific Title:Acronym Research for new biomarker of inflammatory bowel disease (IBD)
Region
Japan

Condition
Condition Inflammatory bowel disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Recently, for diagnosis and the evaluation of inflammatory bowel disease (IBD), the effectiveness of noninvasive examination such as CT, MRI, and blood CRP level instead of invasive colonoscopy examination has been evaluated. However, the effectiveness of these examination has not been elucidated yet. In this study, using blood trace element, fibrosis marker, oxidative related marker, immunologic marker, and stool marker such as calprotectin, fecal occult blood, we aimed to research new biomarker for IBD patients to diagnose and evaluation of disease condition.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To evaluate the correlation between endoscopic disease condition and biomarkers after one week of sampling.
Key secondary outcomes To evaluate the change of biomarkers by the treatment for IBD.

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
20 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria The patients diagnosed as ulcerative colitis and Crohn's disease based on the criteria of Japanese Ministry of Health, Specific disease intractable inflammation-related intestinal tract disorder research group.
Key exclusion criteria a) Re-registration example to the examination
b) The patients with malignant tumor
c) The patients with surgical operation within 12 weeks
d) In addition, the patient who judged an arrangement to the examination if the medical attendant was inappropriate
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuji Naito
Organization Kyoto Prefectural University of Medicine
Division name Molecular Gastroenterology and Hepatology
Zip code
Address 465 Kajiicho Hirokoji Kawaramachidori Kamigyo-ku Kyoto, Japan
TEL 075-251-5519
Email ynaito@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohisa Takagi
Organization Kyoto Prefectural University of Medicine
Division name Molecular Gastroenterology and Hepatology
Zip code
Address 465 Kajiicho Kawaramachidori Kamigyo-ku Kyoto, Japan Kajiicho Hirokoji Kawaramachidori Kamigyo-ku Ky
TEL 075-251-5519
Homepage URL
Email takatomo@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Takeda Pharmaceutical company
Organization
Division
Category of Funding Organization Profit organization
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
2015 Year 08 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 Open public recruiting
Date of protocol fixation
2015 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The entry of patients will be dome from now.

Management information
Registered date
2015 Year 06 Month 06 Day
Last modified on
2018 Year 07 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020655

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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