UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017976 |
|---|---|
| Receipt number | R000020818 |
| Scientific Title | Translational research to investigate the association between peripheral neuropathy by Abraxane and SNPs |
| Date of disclosure of the study information | 2015/06/20 |
| Last modified on | 2019/07/17 10:35:46 |
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Basic information
Public title
Translational research to investigate the association between peripheral neuropathy by Abraxane and SNPs
Acronym
Translational research of peripheral neuropathy by Abraxane and SNPs
Scientific Title
Translational research to investigate the association between peripheral neuropathy by Abraxane and SNPs
Scientific Title:Acronym
Translational research of peripheral neuropathy by Abraxane and SNPs
Region
| Japan |
Condition
Condition
Metastatic or recurrent breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the association between grade 2 and more peripheral neuropathy by Abraxane and SNPs in patients who participate in ABROAD study.
Basic objectives2
Others
Basic objectives -Others
Association between grade 2 and more peripheral neuropathy by Abraxane and SNPs
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
Association between grade 2 and more peripheral neuropathy by Abraxane and SNPs
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Participation in ABROAD study (UMIN 000015516)
2) Institutional review board (IRB) approval for research and transportation of blood samples
3) Written informed consent to participate in this study
Key exclusion criteria
1) Patients not adequate for participation in this study at doctors' discretion.
2) Patients not obtained informed consent
Target sample size
138
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumikata Hara |
Organization
National Hospital Organization Shikoku Cancer Center
Division name
Department of breast oncology
Zip code
Address
160 Kou, Minamiumemoto-chou, Matsuyama City, Ehime Prefecture 791-0280, Japan
TEL
089-999-1111
hfumikat@shikoku-cc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masami Shimazaki |
Organization
CSPOR-BC
Division name
Secretariat
Zip code
Address
101 Gakkikaikan 2-18-21 Sotokanda, Chiyoda, Tokyo, 101-0021
TEL
03-5294-7288
Homepage URL
http://cspor-bc.or.jp/study/index.html
office-bc@cspor-bc.or.jp
Sponsor or person
Institute
CSPOR-BC
Institute
Department
Personal name
Funding Source
Organization
TAIHO PHARMACEUTICAL CO.,LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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 | 20 | Day |
Related information
URL releasing protocol
http://cspor-bc.or.jp/study/index.html
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 | 02 | Month | 18 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 18 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not applicable
Management information
Registered date
| 2015 | Year | 06 | Month | 19 | 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=R000020818
