UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018185 |
|---|---|
| Receipt number | R000021061 |
| Scientific Title | International multicenter trial on diagnostic power of endocytoscopy for colorectal polyps: internet-based study comparing between the automated diagnostic system and endoscopists |
| Date of disclosure of the study information | 2015/07/10 |
| Last modified on | 2016/01/04 18:46:04 |
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Basic information
Public title
International multicenter trial on diagnostic power of endocytoscopy for colorectal polyps: internet-based study comparing between the automated diagnostic system and endoscopists
Acronym
international trial on diagnostic power of endocytoscopy for colorectal polyps
Scientific Title
International multicenter trial on diagnostic power of endocytoscopy for colorectal polyps: internet-based study comparing between the automated diagnostic system and endoscopists
Scientific Title:Acronym
international trial on diagnostic power of endocytoscopy for colorectal polyps
Region
| Japan | Asia(except Japan) | Australia |
Condition
Condition
colorectal polyps
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify usefulness of an automated diagnosis system by using endoctyscopy for colorectal polyps, with use of internet-based international test
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic ability for small polyps (=<10mm) comparing between endoscopists and EC-CAD
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Small colorectal polyps (=<10mm) which were resected after observation of endocytoscopy between October 2013 and June 2015
Key exclusion criteria
Inflamatory bowel disease, familial adenomatous polyposis, lesions in which clear endoscopic images were not obtained
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichi Mori |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
Address
35-1, Chigasaki-tyuo. Yokohama-shi, JPN
TEL
045-949-7000
ibusiginjp@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichi Mori |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
Address
35-1, Chigasaki-tyuo, Tsuzuki-ku, Yokohama-shi, JPN
TEL
045-949-70000
Homepage URL
ibusiginjp@hotmail.com
Sponsor or person
Institute
Digestive Disease Center, Showa University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research (Yuichi Mori, number 25860564 and 15K19351) from the Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
昭和大学横浜市北部病院 消化器センター
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 10 | 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 | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Internet-based test, which are produced by using endoscopic images, is allocated to both an automated diagnosis sysetm and endoscopists for assessment of accuracy of pathological prediction.
Diganostic accuracies, confidence levels, and reproducibilities are compared between the automated diagnosis system and endoscopists (experts and trainees).
Management information
Registered date
| 2015 | Year | 07 | Month | 03 | Day |
Last modified on
| 2016 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021061
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
