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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006205
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Depart of orthopedic surgery osaka city univercity graduate school of medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007335

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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