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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023001
Receipt No. R000026507
Scientific Title Reproducibility in endoscopic evaluation of lugol-voiding lesions in the esophagus: a validation study in a multicenter cohort trial
Date of disclosure of the study information 2016/07/11
Last modified on 2018/07/23

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Basic information
Public title Reproducibility in endoscopic evaluation of lugol-voiding lesions in the esophagus: a validation study in a multicenter cohort trial
Acronym Reproducibility in endoscopic evaluation of LVL
Scientific Title Reproducibility in endoscopic evaluation of lugol-voiding lesions in the esophagus: a validation study in a multicenter cohort trial
Scientific Title:Acronym Reproducibility in endoscopic evaluation of LVL
Region
Japan

Condition
Condition lugol-voiding lesions(LVL)in the esophagus
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the inter-observer reproducibility in multiple LVLs grading before and after learning.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes inter-observer reproducibility before and after learning.
Key secondary outcomes 1)inter-observer reproducibility before learning.
2)intra-observer reproducibility before learning.
3)inter-observer reproducibility after learning
4)intra-observer reproducibility after learning.
5)inter-intra-observer reproducibility before and after learning.
6)inter-intra-observer reproducibility before and after learning among expert and non-expert endoscopist.


Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Take the first test, and take the second test after lerning for a term of one month, and take the third test after one month.
Interventions/Control_2 Take the first test, and take the second test after one month, and take the third test after learning for a term of one month.
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
22 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Endoscopist
Key exclusion criteria nothing
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoyuki Koike
Organization Tohoku University Graduate School of Medicine
Division name Division of Gastroenterology
Zip code
Address 1-1, Seiryo-machi, Aoba-ku, Sendai
TEL 022-711-7171
Email tkoike@rd5.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoyuki Koike
Organization Tohoku University Graduate School of Medicine
Division name Division of Gastroenterology
Zip code
Address 1-1, Seiryo-machi, Aoba-ku, Sendai
TEL 022-711-7171
Homepage URL
Email tkoike@rd5.so-net.ne.jp

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization The Japanese Foundation for Research and Promotion of Endoscopy
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 07 Month 11 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
2016 Year 06 Month 02 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
2017 Year 09 Month 13 Day
Date trial data considered complete
2017 Year 09 Month 14 Day
Date analysis concluded
2017 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 07 Month 04 Day
Last modified on
2018 Year 07 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026507

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2017/09/14 解析(UMIN登録用)20170913.xlsx


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