UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020961 |
|---|---|
| Receipt number | 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 20:08:56 |
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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
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
osa-wata@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Department of Gastroenterology and Hepatology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024181
