UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005294 |
|---|---|
| Receipt number | R000006298 |
| Scientific Title | A study of chemotherapy induced perioheral neuropathy by SNPs |
| Date of disclosure of the study information | 2011/04/01 |
| Last modified on | 2011/03/23 17:29:37 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study of chemotherapy induced perioheral neuropathy by SNPs
Acronym
Peripehral neuropathy and SNPs
Scientific Title
A study of chemotherapy induced perioheral neuropathy by SNPs
Scientific Title:Acronym
Peripehral neuropathy and SNPs
Region
| Japan |
Condition
Condition
Breast and epitherial ovarian cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To identify SNPs to induce chemotherapy-induced peripheral neuropathy
Basic objectives2
Others
Basic objectives -Others
To identify the risk of peripheral neuropathy induced by taxane based chemotherapy regimens
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To identify risk of peripheral neuropathy by SNPs
Key secondary outcomes
Timing of appearance of neuropathy
Timing of disappearance of neuropathy
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Gene |
Interventions/Control_1
Peripheral blood to draw DNA
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
Male and Female
Key inclusion criteria
No previous history of taxane containing regimens sho will start taxane based chemotherapy regimens
Key exclusion criteria
Diabetes
Metastases to brain
Neuropathic patients
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chikako Shimizu |
Organization
National Cancer Center Hospital
Division name
Breast and Medical Oncology Division
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Hashimoto |
Organization
National Cancer Center Hospital
Division name
Breast and Medical Oncology Division
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
kehashim@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Breast and Medical Oncology Division
Institute
Department
Personal name
Funding Source
Organization
Ministory of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
国立がん研究センター中央病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 03 | Month | 23 | Day |
Last modified on
| 2011 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006298
