UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011475
Receipt number R000013430
Scientific Title Research for establishing the best algorithm for breast reconstruction in Japan
Date of disclosure of the study information 2013/08/14
Last modified on 2013/08/16 13:23:49

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Basic information

Public title

Research for establishing the best algorithm for breast reconstruction in Japan

Acronym

Breast reconstruction algorithm in Japan

Scientific Title

Research for establishing the best algorithm for breast reconstruction in Japan

Scientific Title:Acronym

Breast reconstruction algorithm in Japan

Region

Japan


Condition

Condition

Breast cancer

Classification by specialty

Breast surgery Plastic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To establish the best algorithm for breast reconstruction in Japan

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Patient's satisfaction after breast reconstruction

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


Not applicable

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

Patients who provided written consent form on their voluntary basis.

Key exclusion criteria

Patients who were judged inappropriate as subjects

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshitaka Kubota

Organization

Chiba University

Division name

Department of Plastic Surgery

Zip code


Address

1-8-1, Inohana, Chuo-ku, Chiba-city, Japan

TEL

81-43-222-7171

Email



Public contact

Name of contact person

1st name
Middle name
Last name Yoshtiaka Kubota

Organization

Chiba University

Division name

Department of Plastic Surgery

Zip code


Address

1-8-1, Inohana, Chuo-ku, Chiba-city, Japan

TEL

043-222-7171

Homepage URL


Email

kubota-cbu@umin.ac.jp


Sponsor or person

Institute

Department of Plastic Surgery, Chiba University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

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

2013 Year 08 Month 14 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

2012 Year 09 Month 26 Day

Date of IRB


Anticipated trial start date

2013 Year 08 Month 14 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Uncontrolled, non-randomized, open-label


Management information

Registered date

2013 Year 08 Month 13 Day

Last modified on

2013 Year 08 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013430


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name