UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041233 |
|---|---|
| Receipt number | R000047085 |
| Scientific Title | Clinical Outcome of Multicatheter BrAchyTherapy (COMBAT) for 2 Days UltrashOrt PBI (COMBAT-DUO) |
| Date of disclosure of the study information | 2020/07/28 |
| Last modified on | 2020/07/28 15:04:00 |
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Basic information
Public title
Clinical Outcome of Multicatheter BrAchyTherapy (COMBAT) for 2 Days UltrashOrt PBI (COMBAT-DUO)
Acronym
Clinical Outcome of 2 Days UltrashOrt PBI (COMBAT-DUO)
Scientific Title
Clinical Outcome of Multicatheter BrAchyTherapy (COMBAT) for 2 Days UltrashOrt PBI (COMBAT-DUO)
Scientific Title:Acronym
Clinical Outcome of 2 Days UltrashOrt PBI (COMBAT-DUO)
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
evaluation of safety
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
safety
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
4 fracture for 2 days
Interventions/Control_2
8 fracture for 5 days
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Patients with histopathologically confirmed breast cancer before breast-conserving surgery
2) Patients with clinical stages I to III
3) Breast cancer patients with a maximum tumor diameter of 3 cm or less
4) Patients scheduled to undergo breast-conserving surgery
5)Patients who obtained their informed written consent after receiving a sufficient explanation for participation in this study
Key exclusion criteria
1) Patients who have undergone mastectomy
2) Patients with local recurrence
3) Patients with breast Paget's disease
4) Patients with collagen disease
5) Patients who are pregnant or may be pregnant
6)patients who the investigator determined to be inappropriate for the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Sato |
Organization
Tokyo-west Tokushukai Hospital
Division name
Breast Oncology center
Zip code
196-0003
Address
3-1-1 Matsubara-cho Akishima-city Tokyo
TEL
0425004433
kazsato@lake.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Sato |
Organization
Tokyo-west Tokushukai Hospital
Division name
Breast Oncology center
Zip code
196-0003
Address
3-1-1 Matsubara-cho Akishima-city Tokyo
TEL
0425004433
Homepage URL
kazsato@lake.ocn.ne.jp
Sponsor or person
Institute
Tokyo-west Tokushukai Hospital
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 Iryou Research Center inc.
Address
3F Emina-building 1-8-7 Kojimachi Chiyoda-ward Tokyo
Tel
+81332634801
cho@mirai-iryo.com
Secondary IDs
Secondary IDs
YES
Study ID_1
TGE01503-060
Org. issuing International ID_1
Mirai Iryou Research Center inc.
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 28 | 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
| 2020 | Year | 07 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 28 | Day |
Last modified on
| 2020 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047085
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
