UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030408 |
|---|---|
| Receipt number | 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 12:56:45 |
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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
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
ymiyoshi@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034725
