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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028413
Receipt No. R000032436
Scientific Title Learning curve for predicting the invasion depth of early gastric cancer by conventional endoscopy.
Date of disclosure of the study information 2017/07/28
Last modified on 2019/05/02

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Basic information
Public title Learning curve for predicting the invasion depth of early gastric cancer by conventional endoscopy.
Acronym Learning curve for predicting the invasion depth of early gastric cancer by conventional endoscopy.
Scientific Title Learning curve for predicting the invasion depth of early gastric cancer by conventional endoscopy.
Scientific Title:Acronym Learning curve for predicting the invasion depth of early gastric cancer by conventional endoscopy.
Region
Japan

Condition
Condition Gastric cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the effectiveness of an internet-based e-learning system, which consists of video lectures and self-training tests, for improving the ability to predict the invasion depth of early gastric cancer by conventional endoscopy.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The difference of diagnostic accuracy in post-test2.
Key secondary outcomes 1. The difference in the degree of improvement in the post-test1 and post-test2 according to pre-test score, experience of endoscopy and institutional difference.
2. The changes in diagnostic
accuracy between Pre-test and Post-test1.
3. The changes in diagnostic accuracy throughout self-training test program in every 10 cases.
4. Relationship between depth of invasion and the following endoscopic features: tumor location, macroscopic type,
tumor size, histological type and endoscopic findings (non-extension sign, remarkable redness, uneven surface, margin elevation, and enlarged folds).

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Take pre-test, watch video lecture, and take post-test1. Then, take self-training tests, and take post-test2.
Interventions/Control_2 Take pre-test, watch video lecture, and take post-test1. Then, take post-test2.
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 Endoscopists who provided consent to participate in the study.
Key exclusion criteria None.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriya Uedo
Organization Osaka International Cancer Institute
Division name Department of Gastrointestinal Oncology
Zip code
Address 3-1-69 Otemae Tyuo-ku, Osaka 541-8567, Japan
TEL 06-6945-1181
Email noriya.uedo@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Minoru Kato
Organization Osaka International Cancer Institute
Division name Department of Gastrointestinal Oncology
Zip code
Address 3-1-69 Otemae Tyuo-ku, Osaka 541-8567, Japan
TEL 06-6945-1181
Homepage URL
Email katominoru514@gmail.com

Sponsor
Institute Osaka International Cancer Institute
Institute
Department

Funding Source
Organization Fukuoka University Research Institute for Endoscopy
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Fukuoka University Chikushi Hospital
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
2017 Year 07 Month 28 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 07 Month 07 Day
Date of IRB
2016 Year 07 Month 07 Day
Anticipated trial start date
2017 Year 08 Month 01 Day
Last follow-up date
2018 Year 03 Month 30 Day
Date of closure to data entry
2018 Year 04 Month 20 Day
Date trial data considered complete
2018 Year 04 Month 21 Day
Date analysis concluded
2018 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 07 Month 27 Day
Last modified on
2019 Year 05 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032436

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2018/04/21 180421UMIN登録情報.xls


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