UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003879 |
|---|---|
| Receipt number | R000004670 |
| Scientific Title | The study of evaluating the efficacy of MR Enterocolonography for CD lesions in the small bowel and the colon by comparing its findings to those of endoscopy |
| Date of disclosure of the study information | 2010/07/06 |
| Last modified on | 2010/07/06 18:13:40 |
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Basic information
Public title
The study of evaluating the efficacy of MR Enterocolonography for CD lesions in the small bowel and the colon by comparing its findings to those of endoscopy
Acronym
The study of evaluating the efficacy of MR Enterocolonography for CD lesions in the small bowel and the colon by comparing its findings to those of endoscopy
Scientific Title
The study of evaluating the efficacy of MR Enterocolonography for CD lesions in the small bowel and the colon by comparing its findings to those of endoscopy
Scientific Title:Acronym
The study of evaluating the efficacy of MR Enterocolonography for CD lesions in the small bowel and the colon by comparing its findings to those of endoscopy
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to evaluate the diagnostic performance of MR enterocolonography by comparing results of this procedure to those of endoscopies for evaluating the small and large bowel lesions of patients with Crohn's disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcomes is to evaluate sensitivity and specificity of MR Enterocolonography comparing to endoscopic mucosal lesions and stenosis.
Key secondary outcomes
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Ileocolonoscopy or Double-balloon endoscopy
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients had been diagnosed with crohn's disease
Key exclusion criteria
patients complicated for endoscopy (i.e. perforation)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masakazu Nagahori |
Organization
School of Medicine, Tokyo Medical and Dental University
Division name
Gastroenterology and Hepatology
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
School of Medicine, Tokyo Medical and Dental University
Division name
Gastroenterology and Hepatology
Zip code
Address
TEL
03-5803-5877
Homepage URL
Sponsor or person
Institute
School of Medicine, Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2010 | Year | 07 | Month | 06 | 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
| 2009 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 07 | 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
Management information
Registered date
| 2010 | Year | 07 | Month | 06 | Day |
Last modified on
| 2010 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004670
