UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000039307
Receipt No. 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

* 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 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
Email 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
Email tasakamo@ncc.go.jp

Sponsor
Institute National Cancer Center
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044831

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2020/09/11 J-NET 日本人エキスパート(UMIN固定用20200911).xlsx


Contact us.