UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028413 |
|---|---|
| Receipt number | 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 21:02:22 |
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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
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
katominoru514@gmail.com
Sponsor or person
Institute
Osaka International Cancer Institute
Institute
Department
Personal name
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
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
Value
https://center6.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 |
