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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024177
Receipt No. 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

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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
Email 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
Email take5times@hotmail.co.jp

Sponsor
Institute Department of Gastroenterology, Fukuoka University Chikushi Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027788

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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