UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039307 |
|---|---|
| Receipt number | R000044831 |
| Scientific Title | Study on diagnostic accuracy and new findings using endoscopic images |
| Date of disclosure of the study information | 2020/01/29 |
| Last modified on | 2021/01/29 10:00:26 |
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Basic information
Public title
Study on diagnostic accuracy of JNET classification
Acronym
Diagnostic accuracy of JNET classification
Scientific Title
Study on diagnostic accuracy and new findings using endoscopic images
Scientific Title:Acronym
Study on diagnostic accuracy and new findings using endoscopic images
Region
| Japan | Europe |
Condition
Condition
Colorectal polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the reliability of JNET classification
Basic objectives2
Others
Basic objectives -Others
-To examine the diagnostic accuracy of JNET classification in Europe
-To examine the efficacy of e-learning system for JNET classification
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The concordance rate calculated as the percentage of the same judgment for each case among multiple interpreters
Key secondary outcomes
-The diagnostic accuracy (sensitivity and specificity) for histology
-The difference between two times on-line survey regarding the rate of improvement of these results.
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
Not applicable
Key exclusion criteria
Not applicable
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Saito |
Organization
National Cancer Center Hospital, Tokyo
Division name
Endoscopy Division
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
ytsaito@ncc.go.jp
Public contact
Name of contact person
| 1st name | Taku |
| Middle name | |
| Last name | Sakamoto |
Organization
National Cancer Center Hospital, Tokyo
Division name
Endoscopy Division
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
tasakamo@ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Institutional Review Board of the National Cancer Center
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
Tel
03-3542-2511
ncch-irb@ml.res.ncc.go.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
| 2020 | Year | 01 | Month | 29 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
| 2020 | Year | 09 | Month | 11 | Day |
Date analysis concluded
Other
Other related information
Not applicable
Management information
Registered date
| 2020 | Year | 01 | Month | 29 | Day |
Last modified on
| 2021 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044831
