UMIN-CTR Clinical Trial

Basic information
Public title	Prospective observational study to evaluate the usefulness of breast reconstruction combined with fat injection
Acronym	The usefulness of breast reconstruction combined with fat injection
Scientific Title	Prospective observational study to evaluate the usefulness of breast reconstruction combined with fat injection
Scientific Title:Acronym	The usefulness of breast reconstruction combined with fat injection
Region	Japan

Condition
Condition	Breast cancer
Classification by specialty	Plastic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim in the study is to evaluate the usefulness of breast reconstruction combined with fat injection after breast resection and to achieve further optimization of treatment in the future.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Postoperative cosmetic result, QOL, and satisfaction
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	Applicant for fat transfer
Key exclusion criteria	The patient with infection and Advanced breast cancer
Target sample size	80

Research contact person
Name of lead principal investigator	1st name YOSHIHIRO Middle name Last name SOWA
Organization	Kyoto Prefectural University of Medicine, Graduate School of Medical Sciences
Division name	Departments of Plastic and Reconstructive Surgery
Zip code	6028566
Address	kyoto city
TEL	0752515730
Email	sowawan@koto.kpu-m.ac.jp

Public contact
Name of contact person	1st name yoshihiro Middle name Last name sowa
Organization	Kyoto Prefectural University of Medicine, Graduate School of Medical Sciences
Division name	Departments of Plastic and Reconstructive Surgery
Zip code	6028566
Address	kyoto city
TEL	0752515730
Homepage URL
Email	sowawan@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine, Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization	Kyoto Prefectural University of Medicine, Graduate School of Medical Sciences
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	ethical board of KPUM
Address	Kawaramachi-Hirokoji Kajii-cho 465, Kamigyo-ku, Kyoto 602-8566, Japan.
Tel	0752515337
Email	sowawan@koto.kpu-m.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

Other administrative information
Date of disclosure of the study information	2018 Year 08 Month 01 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	2018 Year 08 Month 01 Day
Date of IRB	2018 Year 10 Month 29 Day
Anticipated trial start date	2018 Year 08 Month 01 Day
Last follow-up date	2022 Year 02 Month 22 Day
Date of closure to data entry	2022 Year 02 Month 22 Day
Date trial data considered complete	2022 Year 02 Month 22 Day
Date analysis concluded	2022 Year 02 Month 22 Day

Other
Other related information	non

Management information
Registered date	2018 Year 06 Month 22 Day
Last modified on	2022 Year 02 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037669