UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Patient survey using BreastQ Reconstruction module (Japanese edition)
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Yukiko Kuramoto
Organization	Cancer Institute Hospital
Division name	Department of Plastic and Reconstructive Surgery
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	Yukiko Kuramoto
Organization	Cancer Institute Hospital
Division name	Department of Plastic and Reconstructive Surgery
Address	3-8-31 Ariake, Koutou-ku, Tokyo, 135-8550 Japan
TEL	03-3520-0111
Homepage URL
Email	yukiko.kuramoto@jfcr.or.jp

Sponsor
Institute	Cancer Institute Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 09 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026317