UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017857 |
|---|---|
| Receipt number | R000020512 |
| Scientific Title | Cohort Study on Febrile Neutropenia in Adjuvant Chemotherapy for Breast Cancer Patients |
| Date of disclosure of the study information | 2015/06/15 |
| Last modified on | 2019/07/17 10:31:35 |
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Basic information
Public title
Cohort Study on Febrile Neutropenia in Adjuvant Chemotherapy for Breast Cancer Patients
Acronym
FN Study on Adjuvant Chemotherapy for Breast Cancer
Scientific Title
Cohort Study on Febrile Neutropenia in Adjuvant Chemotherapy for Breast Cancer Patients
Scientific Title:Acronym
FN Study on Adjuvant Chemotherapy for Breast Cancer
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To observe the frequency and risk factors of febrile neutropenia on (neo-)adjuvant chemotherapy for breast cancer patients
Basic objectives2
Others
Basic objectives -Others
In stage I-III breast cancer patients treated by high risk chemotherapies for febrile neutronenia, its frequency and risk factors are observed prospectively
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency of Febrile Neutropenia
Key secondary outcomes
1) FN in 1st. cycle
2)Grade 4 FN
3)Hospitalization
4) G-CSF
5)Antibiotics
6)Adverse events with FN and RDI
7) Patients with G-CSF
8) FN with or without G-CSF
9) Severe adverse events
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. Female patients with invasive ductal and lobular breast cancer
2. Stage I - III
3. Patients receiving (neo)adjuvant chemotherapy with risk of FN
Key exclusion criteria
Patients with no chemotherapy
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Ishikawa |
Organization
Tokyo Medical University
Division name
Breast Surgery
Zip code
Address
6-7-1 Nishishinjyuku, Shinjyukuku, Tokyo 160-0023
TEL
0333426111
tishik55@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kaise |
Organization
Tokyo Medical University
Division name
Breast Surgery
Zip code
Address
6-7-1
TEL
0333426111
Homepage URL
tishik55@gmail.com
Sponsor or person
Institute
CSPOR-BC
Institute
Department
Personal name
Funding Source
Organization
Kyouwa Hakko Kirin
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
Address
Tel
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
| 2015 | Year | 06 | 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
| 2015 | Year | 04 | Month | 27 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Prospective cohort study on frequency and risk factors of febrile neutropenia in neo- and adjuvant chemotherapy for breast cancer patients
Management information
Registered date
| 2015 | Year | 06 | Month | 10 | Day |
Last modified on
| 2019 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020512
