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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030410
Receipt No. R000034726
Scientific Title Evaluation of treatment efficacy of metastatic breast cancer
Date of disclosure of the study information 2017/12/15
Last modified on 2020/03/15

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Basic information
Public title Evaluation of treatment efficacy of metastatic breast cancer
Acronym PET Recurrence
Scientific Title Evaluation of treatment efficacy of metastatic breast cancer
Scientific Title:Acronym PET Recurrence
Region
Japan

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

Objectives
Narrative objectives1 Evaluation of treatment efficacy of FDG-PET in metastatic breast cancers.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Progression free survival according to metabolic response of FDG-PET.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 FDG-PET examination after start of treatment between 2 to 6 weeks.
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 Metastatic breast cancer patients
Key exclusion criteria None
Target sample size 70

Research contact person
Name of lead principal investigator
1st name Yasuo
Middle name
Last name Miyoshi
Organization Hyogo College of Medicine
Division name Division of Breast and Endocrine, Department of Surgery
Zip code 663-8501
Address Mucogawa 1-1, Nishinomiya, Hyogo 663-8501, Japan
TEL 0798456374
Email ymiyoshi@hyo-med.ac.jp

Public contact
Name of contact person
1st name Yasuo
Middle name
Last name Miyoshi
Organization Hyogo College of medicine
Division name Division of Breast and Endocrine, Department of Surgery
Zip code 663-8501
Address Mucogawa 1-1, Nishinomiya, Hyogo 663-8501, Japan
TEL 0798456374
Homepage URL
Email ymiyoshi@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicne
Institute
Department

Funding Source
Organization Hyogo College of Medicine
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 Institutional Review Board of Hyogo College of Medicine
Address Nukogawa 1-1, Nishinomiya City
Tel 0798456374
Email rinri@hyo-med.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
2017 Year 12 Month 15 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
2014 Year 01 Month 15 Day
Date of IRB
2013 Year 12 Month 25 Day
Anticipated trial start date
2014 Year 01 Month 16 Day
Last follow-up date
2019 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
2017 Year 12 Month 15 Day
Last modified on
2020 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034726

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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