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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000020961
Receipt No. R000024181
Scientific Title Evaluation of diagnosis and treatment of inflammatory bowel diseases.
Date of disclosure of the study information 2016/03/23
Last modified on 2017/02/21

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Basic information
Public title Evaluation of diagnosis and treatment of inflammatory bowel diseases.
Acronym Evaluation of diagnosis and treatment of inflammatory bowel diseases.
Scientific Title Evaluation of diagnosis and treatment of inflammatory bowel diseases.
Scientific Title:Acronym Evaluation of diagnosis and treatment of inflammatory bowel diseases.
Region
Japan

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

Objectives
Narrative objectives1 Upper and lower gastrointestinal endoscopy, small intestine endoscopy and capsule endoscopy are essential for the diagnosis of IBD. Gastrointestinal contrast studies also become an important diagnostic tool. Findings of endoscopy and gastrointestinal contrast study, pathological findings obtained by biopsy and clinical symptoms make definitive diagnosis of IBD. In recent years, fecal occult blood test and fecal calprotectin are used as a biomarker of intestinal inflammation, which is an index of activity of the diseases.
The clinical severity of abdominal pain and diarrhea, the severity of the intestinal lesions obtained by endoscopy determine treatment of IBD patients. As a medical therapy, we can use amino salicylic acid, steroid, immunomodulator, immunosuppresant, biologics, cytapherasis, nutritional therapy and endoscopic balloon dilatation. Surgery is also chosen as surgical treatment.
It is necessary to evaluate the accuracy of diagnosis and the usefulness of these therapy, and we should improve medical care of IBD patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes It is necessary to evaluate the accuracy of diagnosis and the usefulness of these therapy, and we should improve medical care of IBD patients.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria IBD patients who took examinations of endoscopy and received treatment in our hospital
Key exclusion criteria IBD patients of whom we cannot track the subsequent clinical course
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiki Hirooka
Organization Nagoya University Hospital
Division name Department of Endoscopy
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya city
TEL 052-744-2172
Email hirooka@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Osamu Watanabe
Organization Nagoya University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya city
TEL 052-744-2172
Homepage URL
Email osa-wata@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Department of Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization no
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor No
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
2016 Year 03 Month 23 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 Preinitiation
Date of protocol fixation
2016 Year 02 Month 10 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information observation study

Management information
Registered date
2016 Year 02 Month 09 Day
Last modified on
2017 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024181

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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