UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027973 |
|---|---|
| Receipt number | 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 | 2020/01/08 14:20:06 |
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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 | Tsuyoshi |
| Middle name | |
| Last name | Nakagawa |
Organization
Tokyo Medical and Dental University
Division name
Breast Surgery
Zip code
1138519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5261
nakagawa.srg2@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Nakagawa |
Organization
Tokyo Medical and Dental University
Division name
Breast Surgery
Zip code
1138519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5261
Homepage URL
nakagawa.srg2@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
Tokyo Medical and Dental University Hospital of Medicine, Clinical Reserch Center
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-5612
tiken.crc@tmd.ac.jp
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
| 2018 | Year | 06 | Month | 30 | Day |
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
| 2020 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031264
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/01/08 | 臨床研究計画書 通信用電波を用いた非侵襲乳腺腫瘍検出装置の実用可能性の評価研究 Ver1.2.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2020/01/08 | 報告書.xls |
| Research case data | |
|---|---|
| Registered date | File name |
