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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033558
Receipt No. R000038271
Scientific Title A Clinical study regarding the changing rate of the bone strength of patients with hormone-sensitive breast cancer under the postoperative endocrine therapy
Date of disclosure of the study information 2018/09/01
Last modified on 2019/08/01

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Basic information
Public title A Clinical study regarding the changing rate of the bone strength of patients with hormone-sensitive breast cancer under the postoperative endocrine therapy
Acronym The analysis of the bone strength under the postoperative endocrine therapy of breast cancer
Scientific Title A Clinical study regarding the changing rate of the bone strength of patients with hormone-sensitive breast cancer under the postoperative endocrine therapy
Scientific Title:Acronym The analysis of the bone strength under the postoperative endocrine therapy of breast cancer
Region
Japan

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

Objectives
Narrative objectives1 To analysis the effect to the bone strength of the postoperative endocrine therapy of patients with stage 1-3A hormone-sensitive breast cancer by using an ultrasonic bone measurement system, LD-100
Basic objectives2 Others
Basic objectives -Others The observation of changing rate
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changing rate for 12 months after starting the postoperative endocrine therapy in following four items derived by an ultrasonic bone measurement system, LD-100
Thickness of distal end of radius
Thickness of cortical bone of radius
Bone mineral density(BMD) of cancellous bone of radius
Elasticity of cancellous bone of radius
Key secondary outcomes 1) Changing rate in the BMD for the lumbar vertebrae (L1-L4) on DXA
2) Changes in bone metabolism marker and the other date of blood
3) Relation between the bone strength and the activity, BMI and the clinical data
4) Appearance of morbid fracture within the period of this study
5) Efficacy of irisin, plasmalogen and etc as a biomarker and the relation between them and the activity, BMI and the clinical data
6) Stratified analysis of 1)-5)

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 Prevention
Type of intervention
Device,equipment
Interventions/Control_1 measure the distal end of radius by LD-100
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
85 years-old >=
Gender Female
Key inclusion criteria 1) Patients diagnosed with stage 1-3A hormone-sensitive breast cancer and start the postoperative endocrine therapy within the period of this study
2) Estrogen receptor or progesterone receptor positive patients on immunohistochemical staining
3) Those from whom written informed consent regarding this study participation was obtained
Key exclusion criteria 1)those can not attend University Hospital, Kyoto Prefectural University of Medicine
2)those are considered to be ineligible by the chief investigator
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Tetsuya
Middle name
Last name Taguchi
Organization Kyoto Prefectural Univercity of Medicine
Division name Department of Endocrine and Breast Surgery
Zip code 602-8566
Address 465 kajii-cho Kawaramachi Hirokoji kamigyouku Kyoto Japan
TEL 0752515534
Email ttaguchi@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name Satomi
Middle name
Last name Tomida
Organization Kyoto Prefectural Univercity of Medicine
Division name Department of Endocrine and Breast Surgery
Zip code 602-8566
Address 465 kajii-cho Kawaramachi Hirokoji kamigyouku Kyoto Japan
TEL 0752515534
Homepage URL
Email satomida@koto.kpu-m.ac.jp

Sponsor
Institute Department of Endocrine and Breast Surgery,Kyoto Prefectural Univercity of Medicine
Institute
Department

Funding Source
Organization Kyoto Prefectural Univercity of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Department of Endocrine and Breast Surgery,Kyoto Prefectural Univercity of Medicine
Address 465 kajii-cho Kawaramachi Hirokoji kamigyouku Kyoto Japan
Tel 075-251-5111
Email soumu@koto.kpu-m.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
2018 Year 09 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 Enrolling by invitation
Date of protocol fixation
2018 Year 09 Month 01 Day
Date of IRB
2018 Year 10 Month 03 Day
Anticipated trial start date
2019 Year 02 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 07 Month 30 Day
Last modified on
2019 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038271

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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