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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029128
Receipt No. R000033308
Scientific Title A study on the quantitative assessment of breast cosmetic outcome in post-operative irradiation for breast cancer patients
Date of disclosure of the study information 2017/09/19
Last modified on 2017/09/13

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Basic information
Public title A study on the quantitative assessment of breast cosmetic outcome in post-operative irradiation for breast cancer patients
Acronym A study of quantitative assessment of breast cosmetic outcome
Scientific Title A study on the quantitative assessment of breast cosmetic outcome in post-operative irradiation for breast cancer patients
Scientific Title:Acronym A study of quantitative assessment of breast cosmetic outcome
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 cosmesis quantitatively
Basic objectives2 Others
Basic objectives -Others Quantify
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Factor analysis of breast cosmesis
Key secondary outcomes

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 (1) Female patients with breast cancer
(2) Patients' age older>= 20y.o.
(3) Breast-conserving surgery patient
(4) Have two years to live
(5) Signed Informed consent for participation in the study
(6) Performance Status: 0-1
Key exclusion criteria (1) Skin infiltration
(2) Mastectomy patient
(3) Uncontrolled infection or serious complications
(4) Patients with psychiatric disorders unsuitable for the study participation
(5) A history of epilepsy
(6) Doctor in charge judged unsuitable for study participation
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuki Otani
Organization Osaka University
Division name Graduate School of Medicine
Zip code
Address 1-7 Yamadaoka Suita Osaka
TEL 06-6879-5111
Email y.otani@radonc.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuki Otani
Organization Kaizuka City Hospital
Division name Radiology
Zip code
Address 3-10-20 Hori Kaizuka Osaka
TEL 072-422-5865
Homepage URL
Email y.otani@radonc.med.osaka-u.ac.jp

Sponsor
Institute Kaizuka City Hospital
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research (C)
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 09 Month 19 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 Open public recruiting
Date of protocol fixation
2017 Year 06 Month 09 Day
Date of IRB
Anticipated trial start date
2017 Year 09 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 All patients who meet the criteria and receive a medical examination in our facility since September 2017

Management information
Registered date
2017 Year 09 Month 13 Day
Last modified on
2017 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033308

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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