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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027973
Receipt No. R000031264
Scientific Title Evaluation of non-invasive detection system for breast tumor using wireless communication radio wave
Date of disclosure of the study information 2017/07/01
Last modified on 2017/06/28

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Basic information
Public title Evaluation of non-invasive detection system for breast tumor using wireless communication radio wave
Acronym Breast tumor detection radar
Scientific Title Evaluation of non-invasive detection system for breast tumor using wireless communication radio wave
Scientific Title:Acronym Breast tumor detection radar
Region
Japan

Condition
Condition
breast tumor
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 A radar-based breast tumor imaging system is developed using non-invasive wireless communication radio wave and evaluated by clinical tests.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Ability of breast tumor detection
Key secondary outcomes safety

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
Device,equipment
Interventions/Control_1 A radar-based breast tumor imaging system is developed using non-invasive wireless communication radio wave.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Patient with malignant breast tumour who needed to undergo mastectomy
Key exclusion criteria 1.Patient who underwent tumorectomy in the same breast in the past
2.Patient under the pregnancy
3.Patient under the nursing
Target sample size 3

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsuyoshi Nakagawa
Organization Tokyo Medical and Dental University
Division name Breast Surgery
Zip code
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5261
Email nakagawa.srg2@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsuyoshi Nakagawa
Organization Tokyo Medical and Dental University
Division name Breast Surgery
Zip code
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5261
Homepage URL
Email nakagawa.srg2@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Ministry of Education,Culture,Sports,Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2017 Year 07 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 Preinitiation
Date of protocol fixation
2017 Year 06 Month 28 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 01 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
2017 Year 06 Month 28 Day
Last modified on
2017 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031264

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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