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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046199
Receipt No. R000052601
Scientific Title Database Study on Chemotherapy Regimens for Breast Cancer, Use Patterns of G-CSF Preparations, and Development of Febrile Neutropenia
Date of disclosure of the study information 2021/11/26
Last modified on 2021/11/26

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Basic information
Public title Database Study on Chemotherapy Regimens for Breast Cancer, Use Patterns of G-CSF Preparations, and Development of Febrile Neutropenia
Acronym Database Study on Chemotherapy Regimens for Breast Cancer, Use Patterns of G-CSF Preparations, and Development of Febrile Neutropenia
Scientific Title Database Study on Chemotherapy Regimens for Breast Cancer, Use Patterns of G-CSF Preparations, and Development of Febrile Neutropenia
Scientific Title:Acronym Database Study on Chemotherapy Regimens for Breast Cancer, Use Patterns of G-CSF Preparations, and Development of Febrile Neutropenia
Region
Japan

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

Objectives
Narrative objectives1 To clarify the actual status of the chemotherapy regimens, use patterns of G-CSF preparations, development of febrile neutropenia (FN), ,and hospitalization due to FN.
Basic objectives2 Others
Basic objectives -Others To exploratorily investigate factors related to development of FN and hospitalization due to FN.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Use patterns of chemotherapy regimens, use patterns of G-CSF preparations, development of FN, and hospitalization rate for FN
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
18 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria (1) Patients diagnosed with breast cancer during the data period from April 2008 to October 2020
(2) Patients who have undergone breast cancer surgery in the same month or later than the month of the initial diagnosis of breast cancer
Key exclusion criteria (1) Patients < 18 years of age
(2) Male patients
(3) Patients who have been diagnosed with cancer other than breast cancer within 1 year prior to the initial diagnosis of breast cancer
(4) Patients who have received chemotherapy or radiotherapy within 1 year prior to the initial diagnosis of breast cancer
(5) Patients who have received no chemotherapy regimen
Target sample size 410000

Research contact person
Name of lead principal investigator
1st name Tomoyuki
Middle name
Last name Nukada
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
Email ma.oncology@kyowa-kirin.co.jp

Public contact
Name of contact person
1st name Tomoyuki
Middle name
Last name Nukada
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
Email ma.oncology@kyowa-kirin.co.jp

Sponsor
Institute Kyowa Kirin Co., Ltd.
Institute
Department

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 Institute of Healthcare Data Science
Address Sumitomosibadaimon Bld.12F,2-5-5, Shibadaimon, Minato-ku, Tokyo,Japan
Tel 03-5733-5010
Email rihds@jmdc.co.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
2021 Year 11 Month 26 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 Preinitiation
Date of protocol fixation
2021 Year 11 Month 09 Day
Date of IRB
2021 Year 11 Month 09 Day
Anticipated trial start date
2021 Year 11 Month 19 Day
Last follow-up date
2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study will use the DPC data held by Medical Data Vision Co., Ltd.

Management information
Registered date
2021 Year 11 Month 26 Day
Last modified on
2021 Year 11 Month 26 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052601

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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