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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041233
Receipt No. 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

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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
Email 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
Email kazsato@lake.ocn.ne.jp

Sponsor
Institute Tokyo-west Tokushukai Hospital
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 Iryou Research Center inc.
Address 3F Emina-building 1-8-7 Kojimachi Chiyoda-ward Tokyo
Tel +81332634801
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047085

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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