UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024177 |
|---|---|
| Receipt number | R000027788 |
| Scientific Title | Learning effect for diagnosing depth of invasion using "non-extension sign" in early gastric cancer |
| Date of disclosure of the study information | 2016/09/26 |
| Last modified on | 2017/04/27 20:23:36 |
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Basic information
Public title
Learning effect for diagnosing depth of invasion using "non-extension sign" in early gastric cancer
Acronym
Investigation for efficacy of "non-extension sign"
Scientific Title
Learning effect for diagnosing depth of invasion using "non-extension sign" in early gastric cancer
Scientific Title:Acronym
Investigation for efficacy of "non-extension sign"
Region
| Japan |
Condition
Condition
Early gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the learning effect for diagnosing depth of invasion using "non-extension sign" in early gastric cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of accuracy rate between pre-test and post-test in doctor under 80%
Key secondary outcomes
(1)Comparison of accuracy rate between pre-test and post-test by proficiency in doctor over 80%
(2)other,evaluate all the various result
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Lecture about diagnosing depth of invasion using non-extension sign in early gastric cancer
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
| 24 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The doctor who completed the exam
Key exclusion criteria
(1)Head of department
(2)Not participating in the training session
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenshi Yao |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Endoscopy
Zip code
Address
1-1-1, Zokumyoin, Chikushino-city, Fukuoka, Japan
TEL
092-921-1011
yao@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Teruyuki Takeda |
Organization
Tobata Kyoritsu Hospital
Division name
Department of Gastroenterology
Zip code
Address
2-5-1, Sawami, Tobata-ku, Kitakyushu-city, Fukuoka, Japan
TEL
093-871-5421
Homepage URL
take5times@hotmail.co.jp
Sponsor or person
Institute
Department of Gastroenterology, Fukuoka University Chikushi Hospital
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University Chikushi Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
戸畑共立病院（福岡県）
芦屋中央病院（福岡県）
製鉄記念八幡病院（福岡県）
福岡ゆたか中央病院（福岡県）
産業医科大学病院（福岡県）
おんが病院（福岡県）
九州労災病院（福岡県）
田川市立病院（福岡県）
小倉医療センター（福岡県）
和田病院（大分県）
北九州市立医療センター（福岡県）
Tobata Kyoritsu Hospital（Fukuoka）
Ashiya Central Hospital（Fukuoka）
Steel Memorial Yawata Hospital（Fukuoka）
Fukuoka Yutaka Central Hospital（Fukuoka）
Hospital of the University of Occupational and Environmental Health（Fukuoka）
Onga Hospital（Fukuoka）
Kyushu Rosai Hospital（Fukuoka）
Tagawa Municipal Hospital（Fukuoka）
Kokura Medical Center（Fukuoka）
Wada Hospital（Oita）
Kitakyushu Municipal Medical Center（Fukuoka）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 26 | 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
| 2015 | Year | 12 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 26 | Day |
Last modified on
| 2017 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027788
| Research Plan | |
|---|---|
| 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 |
