UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002250 |
|---|---|
| Receipt number | R000002755 |
| Scientific Title | Prediction of the effect of treatments for inflammatory bowel disease patients by using colon ultra sonography imaging |
| Date of disclosure of the study information | 2009/07/25 |
| Last modified on | 2020/08/02 16:40:28 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Prediction of the effect of treatments for inflammatory bowel disease patients by using colon ultra sonography imaging
Acronym
Prediction of the effect of treatments for inflammatory bowel disease patients by using colon ultra sonography imaging
Scientific Title
Prediction of the effect of treatments for inflammatory bowel disease patients by using colon ultra sonography imaging
Scientific Title:Acronym
Prediction of the effect of treatments for inflammatory bowel disease patients by using colon ultra sonography imaging
Region
| Japan |
Condition
Condition
Inflammatory bowel disease(IBD)
Classification by specialty
| Gastroenterology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To classify the colon ultra sonographic image of IBD patients according to theri disease severity and predict the effect of treatment by the colon ultra sonographic image data
Basic objectives2
Others
Basic objectives -Others
efficacy and prediction
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Prediction of efficacy of treatment
Key secondary outcomes
classification
prediction of recurrence
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Perform colon ultrasonography before the treatment of IBD patinets, or in remission state patients.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who diagnosed with criteria of IBD (ulcerative colitis and Crohn's disease) and obtained written informed concent.
Key exclusion criteria
Patients who could not obtain written informed concent.
Target sample size
260
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kanai Takanori |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayama Tetsuro |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
Homepage URL
Sponsor or person
Institute
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University 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
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
| 2009 | Year | 07 | Month | 25 | 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
Date of protocol fixation
| 2009 | Year | 06 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 07 | Month | 25 | Day |
Last modified on
| 2020 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002755
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
