UMIN-CTR Clinical Trial

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
Email	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
Email	office-bc@cspor-bc.or.jp

Sponsor
Institute	CSPOR-BC
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020818