UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050369 |
|---|---|
| Receipt number | R000057327 |
| Scientific Title | Pegfilgrastim On Body Injector Nursing research (patient/Nurse questionnaire research) |
| Date of disclosure of the study information | 2023/02/20 |
| Last modified on | 2023/10/20 09:11:39 |
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Basic information
Public title
Pegfilgrastim On Body Injector Nursing research (patient/Nurse questionnaire research)
Acronym
Pegfilgrastim On Body Injector Nursing research (patient/Nurse questionnaire research)
Scientific Title
Pegfilgrastim On Body Injector Nursing research (patient/Nurse questionnaire research)
Scientific Title:Acronym
Pegfilgrastim On Body Injector Nursing research (patient/Nurse questionnaire research)
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Hematology and clinical oncology | Surgery in general | Breast surgery |
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We clarify the usability, satisfaction, advantages and disadvantages of the pegfilgrastim On Body Injector using a questionnaire study for breast cancer patients and nurses who explain and attach On body Injector
Basic objectives2
Others
Basic objectives -Others
The usability, satisfaction of On Body Injector
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The usability, satisfaction of On Body Injector
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Patients>
1) Patients who provide written consent for participation in this study
2) Breast cancer patients who underwent outpatient chemotherapy by their attending physician and who used a pegfilgrastim On Body Injector(G-Lasta subcutaneous injection 3.6 mg body pod) for the first time
3) Patients who are at least 20 years of age at the time of consent
Nurses>
Nurses who provide written consent for participation in this study
Key exclusion criteria
Patients>
Patients deemed inappropriate by the principal investigator or subinvestigator
Nurses>
Principal investigator and co-investigator of this study
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Tatsuhiko |
| Middle name | |
| Last name | Hosaka |
Organization
Kyowa Kirin Co., Ltd.
Division name
Medical Affairs
Zip code
100-0004
Address
1-9-2, Otemachi, Chiyoda-ku, Tokyo
TEL
03-5205-7200
ma.oncology.g.19@kyowakirin.com
Public contact
Name of contact person
| 1st name | Tatsuhiko |
| Middle name | |
| Last name | Hosaka |
Organization
Kyowa Kirin Co., Ltd.
Division name
Medical Affairs
Zip code
100-0004
Address
1-9-2, Otemachi, Chiyoda-ku, Tokyo
TEL
03-5205-7200
Homepage URL
ma.oncology.g.19@kyowakirin.com
Sponsor or person
Institute
Kyowa Kirin Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kyowa Kirin Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethical Review Committee of Kyowa Kirin Co., Ltd
Address
1-9-2, Otemachi, Chiyoda-ku, Tokyo 100-0004, JAPAN
Tel
03-5205-7200
researchethics.fj@kyowakirin.com
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
| 2023 | Year | 02 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 01 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 19 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 02 | Month | 17 | Day |
Last modified on
| 2023 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057327
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
