UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029128 |
|---|---|
| Receipt number | 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 | 2020/09/16 09:14:49 |
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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 | 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
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
y.otani@radonc.med.osaka-u.ac.jp
Sponsor or person
Institute
Kaizuka City Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033308
