UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044545 |
|---|---|
| Receipt number | R000050890 |
| Scientific Title | International randomized controlled trial for investigating the usefulness of e-learning system which improves pathological diagnosis of gastric cancer. |
| Date of disclosure of the study information | 2021/06/15 |
| Last modified on | 2021/06/15 18:20:06 |
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Basic information
Public title
Development of an e-learning system for the pathologic diagnosis of gastric cancer
Acronym
Global e-learning Study Team for Pathology
Trial (GEST-P)
Scientific Title
International randomized controlled trial for investigating the usefulness of e-learning system which improves pathological diagnosis of gastric cancer.
Scientific Title:Acronym
Global e-learning Study Team for Pathology
Trial (GEST-P)
Region
| Asia(except Japan) | North America | South America |
| Australia | Europe | Africa |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
An e-learning system for Internet-based education of the pathological diagnosis of early gastric cancer has been developed and its usefulness in learning will be evaluated.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The difference in the e-test performance
improvement rate between the e-learning
group and the no e-learning group will be analyzed.
Improvement rate = post-test performance (score)/pre-test performance (score)
Key secondary outcomes
(1) Difference in improvement rate between the group having received education from
Japanese pathologists and the group without such education
(2) Difference in improvement rate depending on the length of career as a pathologist
(3) Difference in improvement rate depending on the country or region (Asia-Oceania, Europe, North America, and Central/South America)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
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
Education by e-learning system
(E-learning group)
Interventions/Control_2
No education by e-learning system
(No e-learning group)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Age 20 and over
2) Physicians who can access the sample e-test and e-learning (movie) and can confirm that the sample works normally on their personal computer browser
3) Physicians who can understand the language (i.e., English) used in the e-test and e-learning
4) Physicians who can answer the questionnaire (sent in advance) completely within 2 weeks
5) Physicians who have submitted the informed consent form for participation in this trial, thereby stating that they have received approval for their participation in this trial from the director of the facility to which they belong
Key exclusion criteria
1)Participants who have failed to complete the pre-test
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Kenshi |
| Middle name | |
| Last name | Yao |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Endoscopy
Zip code
818-8502
Address
1-1-1 Zokumyoin, Chikushino City, Fukuoka 818-8502
TEL
092-921-1011
yao@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenshi |
| Middle name | |
| Last name | Yao |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Endoscopy
Zip code
818-8502
Address
1-1-1 Zokumyoin, Chikushino City, Fukuoka 818-8502
TEL
092-921-1011
Homepage URL
yao@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University Chikushi Hospital
Department of Endoscopy
Institute
Department
Personal name
Funding Source
Organization
Zero Helicobacter IGAN Network-
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka University-Medical Ethics Review Board
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka City, Fukuoka Prefecture
Tel
092-801-1011
fumed-ethics@fukuoka-u.ac.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
福岡大学筑紫病院（福岡県）
Fukuoka University Chikushi Hospital (Fukuoka prefecture, Japan)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 15 | Day |
Last modified on
| 2021 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050890
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
