UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029907 |
|---|---|
| Receipt number | R000034049 |
| Scientific Title | Clinical Outcome of Multicatheter Brachytherapy APBI in breast-conserving Therapy (COMBAT)for breast cancer patients-A(adjuvant),-C(complications and cosmesis) |
| Date of disclosure of the study information | 2017/11/10 |
| Last modified on | 2019/11/28 16:26:39 |
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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
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
hiromi.fuchikami@tokushukai.jp
Sponsor or person
Institute
Tokyo-West Tokushukai Hospital Breast oncology center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034049
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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