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

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 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

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

Value
https://center6.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