UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017831 |
|---|---|
| Receipt number | 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 | 2023/12/11 15:00:04 |
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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 | Yuji |
| Middle name | |
| Last name | Naito |
Organization
Kyoto Prefectural University of Medicine
Division name
Molecular Gastroenterology and Hepatology
Zip code
602-8566
Address
465 Kajiicho Hirokoji Kawaramachidori Kamigyo-ku Kyoto, Japan
TEL
075-251-5519
ynaito@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Tomohisa |
| Middle name | |
| Last name | Takagi |
Organization
Kyoto Prefectural University of Medicine
Division name
Molecular Gastroenterology and Hepatology
Zip code
602-8566
Address
465 Kajiicho Kawaramachidori Kamigyo-ku Kyoto, Japan Kajiicho Hirokoji Kawaramachidori Kamigyo-ku Ky
TEL
075-251-5519
Homepage URL
k-uchi@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
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
Kyoto Prefectural University of Medicine
Address
465 Kajiicho Hirokoji Kawaramachidori Kamigyo-ku Kyoto, Japan Kajiicho Hirokoji Kawaramachidori Kamigyo-ku Kyoto, Japan
Tel
075-251-5337
rinri@koto.kpu-m.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
| 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
Completed
Date of protocol fixation
| 2015 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 25 | 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
The entry of patients will be dome from now.
Management information
Registered date
| 2015 | Year | 06 | Month | 06 | Day |
Last modified on
| 2023 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020655
