UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030019 |
|---|---|
| Receipt number | R000034272 |
| Scientific Title | The evaluation of breast hardness using ultrasound elastgraphy with patient care and the construction of effect measurement model |
| Date of disclosure of the study information | 2017/11/18 |
| Last modified on | 2022/05/30 10:18:42 |
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Basic information
Public title
The evaluation of breast hardness using ultrasound elastgraphy with patient care and the construction of effect measurement model
Acronym
The evaluation of ultrasound elastgraphy for breast hardness
Scientific Title
The evaluation of breast hardness using ultrasound elastgraphy with patient care and the construction of effect measurement model
Scientific Title:Acronym
The evaluation of ultrasound elastgraphy for breast hardness
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate breast stiffness quantitatively and qualitatively using breast ultrasound elastgraphy following breast conserving therapy.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate image findings and elasticity on B mode US with elastgraphy at baseline, one month after surgery, pre-radiation therapy, one month and one year after completion of radiation therapy.
Key secondary outcomes
To evaluate breast cosmesis, radiation induced disorder and subjective assessment.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Breast cancer patients who have a plan to receive breast conserving surgery with radiation therapy.
Key exclusion criteria
Younger than 20 years.
Postoperative breast cancer patients.
Patients who have a plan for bilateral
breast surgery.
Contraindications to radiation therapy.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Misugi |
| Middle name | |
| Last name | Urano |
Organization
Nagoya City University Graduate School of Medical Science
Division name
Radiology
Zip code
4678607
Address
1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya-ci, Aichi
TEL
+81-52-853-8276
m_urano@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Misugi |
| Middle name | |
| Last name | Urano |
Organization
Nagoya City University Graduate School of Medical Science
Division name
Radiology
Zip code
4678607
Address
1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya-ci, Aichi
TEL
+81-52-853-8276
Homepage URL
m_urano@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Science,Radiology.
Institute
Department
Personal name
Funding Source
Organization
MEXT
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
Nagoya City University Graduate School of Medical Science
Address
1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya-ci, Aichi
Tel
052-858-7215
clinical_research@med.nagoya-cu.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 | 11 | Month | 18 | 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
30
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Delayed for COVID-19 status
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 05 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 03 | Month | 01 | Day |
Other
Other related information
No data
Management information
Registered date
| 2017 | Year | 11 | Month | 17 | Day |
Last modified on
| 2022 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034272
| Research Plan | |
|---|---|
| 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 |
