UMIN-CTR Clinical Trial

Basic information
Public title	Clinical Outcome of Multicatheter Brachytherapy APBI in breast-conserving Therapy (COMBAT)for breast cancer patients-A(adjuvant),-C(complications and cosmesis)
Acronym	Clinical Outcome of APBI in breast-conserving Therapy (COMBAT)for breast cancer patients-A(adjuvant),-C(complications and cosmesis)
Scientific Title	Clinical Outcome of Multicatheter Brachytherapy APBI in breast-conserving Therapy (COMBAT)for breast cancer patients-A(adjuvant),-C(complications and cosmesis)
Scientific Title:Acronym	Clinical Outcome of APBI in breast-conserving Therapy (COMBAT)for breast cancer patients-A(adjuvant),-C(complications and cosmesis)
Region	Japan

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

Objectives
Narrative objectives1	Cosmesis is important in breast-conserving surgery. We started partial irradiation by multi catheter brachytherapy at our hospital about 9 years ago, and we will study long-term cosmesis including self-evaluation of patients after breast-conserving and partial irradiation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Long term 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	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Patients who satisfy all of the following criteria 1) Patients who are confirmed to be breast cancer histopathologically before breast-conserving surgery 2) Patients in clinical stage 0 to III 3) Patients with breast cancer whose maximum tumor size is 3 cm or less 4) Patients who have undergone or will receive breast conservation 5) female patient
Key exclusion criteria	Patients who conflict with one of the following 1) Patients with collagen disease 2) Pregnant or possibly having a possibility 3) Other patients judged inappropriate
Target sample size	850

Research contact person
Name of lead principal investigator	1st name Hiromi Middle name Last name Fuchikami
Organization	Tokyo-West Tokushukai Hospital
Division name	Breast Oncology center
Zip code	1960003
Address	3-1-1 Matsubara-cho Akishima--city Tokyo
TEL	0425004433
Email	hiromi.fuchikami@tokushukai.jp

Public contact
Name of contact person	1st name Hiromi Middle name Last name Fuchikami
Organization	Tokyo-West Tokushukai Hospital
Division name	Breast oncology center
Zip code	1960003
Address	3-1-1 Matsubara-cho-Akishima-city Tokyo
TEL	042-500-4433
Homepage URL
Email	hiromi.fuchikami@tokushukai.jp

Sponsor
Institute	Tokyo-West Tokushukai Hospital Breast oncology center
Institute
Department

Funding Source
Organization	Tokyo-West Tokushukai Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Mirai Iryo Research Center Inc.
Address	1-8-7, Koji-machi, Chiyoda-ku, Tokyo 102-0083, Japan
Tel	03-3263-4801
Email	utsugi@mirai-iryo.com

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	東京西徳洲会病院

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 10 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	Enrolling by invitation
Date of protocol fixation	2017 Year 11 Month 06 Day
Date of IRB	2017 Year 11 Month 06 Day
Anticipated trial start date	2017 Year 11 Month 11 Day
Last follow-up date	2031 Year 11 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Regarding the evaluation of cosmesis, we mainly use photographs based on Harvard 's cosmesis evaluation scale and cosmesis analysis software (BCCT.CORE SOFTWARE: use permission acquired).

Management information
Registered date	2017 Year 11 Month 10 Day
Last modified on	2019 Year 11 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034049