UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024057 |
|---|---|
| Receipt number | 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 18:24:08 |
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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
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
hmatsumoto0311@gmail.com
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016330
