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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024057
Receipt No. R000016330
Scientific Title Evaluation of a standardized CT colonography Training Program
Date of disclosure of the study information 2016/11/01
Last modified on 2019/10/16

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Basic information
Public title Evaluation of a standardized CT colonography Training Program
Acronym Evaluation of a standardized CT colonography Training Program
Scientific Title Evaluation of a standardized CT colonography Training Program
Scientific Title:Acronym Evaluation of a standardized CT colonography Training Program
Region
Japan

Condition
Condition colorectal tumor
Classification by specialty
Gastroenterology Radiology Laboratory medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine how many CT colonography training studied have to be evaluated by novice readers to obtain an adequate level of competence in polyp detection
Basic objectives2 Others
Basic objectives -Others Is it different training numbers for gastroenterologist and radiologist?
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The number of CT colonography examinations for sufficient sensitivity and specifity
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)gastroenterologist
2)radiologist
3)radilogical doctor
Key exclusion criteria person who has already trained of CT colonograpy
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Matsumoto
Organization Kawasaki Medical School
Division name Gastroenterology
Zip code
Address Matsushima 577, Kurashiki city, Okayama
TEL 0864621111
Email hmatsumoto0311@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Matsumoto
Organization Kawasaki Medical School
Division name Gastroenterology
Zip code
Address Matsushima 577, Kurashiki city, Okayama
TEL 0864621111
Homepage URL
Email hmatsumoto0311@gmail.com

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization Kawasaki Medical School
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

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 01 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 10 Month 31 Day
Date of IRB
2016 Year 09 Month 08 Day
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
2019 Year 10 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information public offer after open

Management information
Registered date
2016 Year 09 Month 14 Day
Last modified on
2019 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016330

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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