UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022835
Receipt number R000026317
Scientific Title Patient survey using BreastQ Reconstruction module (Japanese edition)
Date of disclosure of the study information 2016/07/30
Last modified on 2016/06/22 10:58:25

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Basic information

Public title

Patient survey using BreastQ Reconstruction module (Japanese edition)

Acronym

Patient survey using BreastQ

Scientific Title

Patient survey using BreastQ Reconstruction module (Japanese edition)

Scientific Title:Acronym

Patient survey using BreastQ

Region

Japan


Condition

Condition

Breast Cancer

Classification by specialty

Plastic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

We investigate patients satisfaction by BreastQ for the patients who underwent breast reconstruction .

Basic objectives2

Others

Basic objectives -Others

The objective of this study was to compare the satisfaction of breast reconstruction in implant-based reconstruction versus autologus reconstruction.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Patients satisfaction by BreastQ

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

BreastQ

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

Patient of breast reconstruction

Key exclusion criteria

Those whom we considre inappropiate due to physical and/or mental problem

Target sample size

500


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yukiko Kuramoto

Organization

Cancer Institute Hospital

Division name

Department of Plastic and Reconstructive Surgery

Zip code


Address

3-8-31 Ariake, Koutou-ku, Tokyo, 135-8550 Japan

TEL

03-3520-0111

Email

yukiko.kuramoto@jfcr.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yukiko Kuramoto

Organization

Cancer Institute Hospital

Division name

Department of Plastic and Reconstructive Surgery

Zip code


Address

3-8-31 Ariake, Koutou-ku, Tokyo, 135-8550 Japan

TEL

03-3520-0111

Homepage URL


Email

yukiko.kuramoto@jfcr.or.jp


Sponsor or person

Institute

Cancer Institute Hospital

Institute

Department

Personal name



Funding Source

Organization

Cancer Institute Hospital

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

2016 Year 07 Month 30 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

Preinitiation

Date of protocol fixation

2016 Year 09 Month 01 Day

Date of IRB


Anticipated trial start date

2016 Year 10 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



Management information

Registered date

2016 Year 06 Month 22 Day

Last modified on

2016 Year 06 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026317


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name