UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055844 |
|---|---|
| Receipt number | R000063753 |
| Scientific Title | Evaluation of injection site reactions caused by Fulvestrant injection and investigation of safe and reliable administration methods |
| Date of disclosure of the study information | 2024/10/15 |
| Last modified on | 2025/10/17 16:53:34 |
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Basic information
Public title
Evaluation of injection site reactions caused by Fulvestrant injection and investigation of safe and reliable administration methods
Acronym
Evaluation of Fulvestrant injection site
Scientific Title
Evaluation of injection site reactions caused by Fulvestrant injection and investigation of safe and reliable administration methods
Scientific Title:Acronym
Evaluation of Fulvestrant injection site
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of injection site
Review of injection technique
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ultrasound findings at the injection site
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Ultrasound examination of the injection site
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
Male and Female
Key inclusion criteria
Breast cancer patients receiving fulvestrant
Key exclusion criteria
None
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Nana |
| Middle name | |
| Last name | Kamikura |
Organization
Breast and Imaging Center, St. Marianna University School of Medicine, Kawasaki-Shi, Japan
Division name
Nursing care
Zip code
215-0004
Address
6-7-2 Manpukuji Asao-Ku Kawasaki City Kanagawa
TEL
044-969-7720
n.kamikura@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Nana |
| Middle name | |
| Last name | Kamikura |
Organization
Breast and Imaging Center, St. Marianna University School of Medicine, Kawasaki-Shi, Japan
Division name
Nursing care
Zip code
215-0004
Address
6-7-2 Manpukuji Asao-Ku Kawasaki City Kanagawa
TEL
044-969-7720
Homepage URL
n.kamikura@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Bioethics Committee, St. Marianna University School of Medicine
Address
2-16-1 Sugao Miyamae-Ku Kawasaki City Kanagawa zip216-851
Tel
0449778111
N/A
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
| 2024 | Year | 10 | 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
Completed
Date of protocol fixation
| 2024 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 08 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 10 | Month | 15 | Day |
Last modified on
| 2025 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063753
