UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006205 |
|---|---|
| Receipt number | R000007335 |
| Scientific Title | evaluation of soft tissue tumor using ultrasonography |
| Date of disclosure of the study information | 2011/08/20 |
| Last modified on | 2011/08/20 14:41:45 |
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Basic information
Public title
evaluation of soft tissue tumor using ultrasonography
Acronym
evaluation of soft tissue tumor using ultrasonography
Scientific Title
evaluation of soft tissue tumor using ultrasonography
Scientific Title:Acronym
evaluation of soft tissue tumor using ultrasonography
Region
| Japan |
Condition
Condition
soft tissue tumor
Classification by specialty
| Orthopedics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The contrast medium is used together with the ultrasonography for the soft tisue tumor, and it makes comparative study of the image opinion obtained there with organizational basis (WHO classification) and malignancy classification (FNCLCC grade). It is examined whether the ultrasonography is effective about the presence of the specific finding by each organization and the guess of the malignancy. Moreover, it examines whether to lead to the accuracy improvement of the discrimination of the malignancy at the same time using the elasticity measurement device established as an annex in the supersonic wave equipment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
gray scale
color doppler
power doppler
elast graphy
color doppler with contrast medium
Key secondary outcomes
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
| Medicine |
Interventions/Control_1
sonazoid
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
| 0 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patient who explains outline of content of present study and obtains agreement
Key exclusion criteria
Patient who doesn't obtain agreement in present study
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hoshi Manabu |
Organization
osaka city univercity graduate school of medicine
Division name
orthopedoc surgery
Zip code
Address
1-4-3., Asahimachi, Abeno-ku, Osaka, 545-8585 Japan
TEL
06-6645-3851
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Oebisu Naoto |
Organization
osaka city univercity graduate school of medicine
Division name
orthopedic surgery
Zip code
Address
1-4-3., Asahimachi, Abeno-ku, Osaka, 545-8585 Japan
TEL
Homepage URL
Sponsor or person
Institute
Depart of orthopedic surgery osaka city univercity graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
| 2011 | Year | 08 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 20 | Day |
Last modified on
| 2011 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007335
| 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 |
