UMIN-CTR Clinical Trial

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 Yuki Middle name Last name Otani
Organization	Osaka University
Division name	Graduate School of Medicine
Zip code	565-0871
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 Yuki Middle name Last name Otani
Organization	Kaizuka City Hospital
Division name	Radiology
Zip code	597-0015
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	Kaizuka City Hospital
Address	3-10-20 Hori Kaizuka Osaka
Tel	072-422-5865
Email	y.otani@radonc.med.osaka-u.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	市立貝塚病院

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	No longer recruiting
Date of protocol fixation	2017 Year 06 Month 09 Day
Date of IRB	2017 Year 06 Month 09 Day
Anticipated trial start date	2017 Year 09 Month 01 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	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	2020 Year 09 Month 16 Day

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