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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030408
Receipt No. R000034725
Scientific Title Evaluation of efficacy due to response by FDG-PET in breast cancers treated with neoadjuvant chemotherapy
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 efficacy due to response by FDG-PET in breast cancers treated with neoadjuvant chemotherapy
Acronym PET NAC
Scientific Title Evaluation of efficacy due to response by FDG-PET in breast cancers treated with neoadjuvant chemotherapy
Scientific Title:Acronym PET NAC
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 by FDG-PET in breast cancers treated with neoadjuvant chemotherapy.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Response rate
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 between 2 to 6 weeks after start of neoadjuvant chemotherapy.
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 Primary breast cancer patients treated with neoaduvant chemotherapy.
Key exclusion criteria Patients with Li-Fraumeni syndrome.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Miyoshi
Middle name
Last name Yasuo
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 Medicine
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 Mukogawa 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 Unpublished
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/30941655
Number of participants that the trial has enrolled 199
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2019 Year 07 Month 01 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 05 Month 01 Day
Date of IRB
2014 Year 05 Month 25 Day
Anticipated trial start date
2014 Year 06 Month 01 Day
Last follow-up date
2019 Year 12 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=R000034725

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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