UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046199
Receipt number 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 2023/11/28 09:37:12

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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 January 2010 to April 2020
(2)From January 2010 to April 2020, 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 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 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

33000

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

No longer recruiting

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

2023 Year 11 Month 28 Day



Link to view the page

Value
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