UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030019
Receipt No. 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 2019/05/21

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email m_urano@med.nagoya-cu.ac.jp

Sponsor
Institute Nagoya City University Graduate School of Medical Science,Radiology.
Institute
Department

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
Email 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
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 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

Other
Other related information No data

Management information
Registered date
2017 Year 11 Month 17 Day
Last modified on
2019 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034272

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.