UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001231 |
|---|---|
| Receipt number | R000001435 |
| Scientific Title | Exploratory research to investigate the single nucleotide polymorphisms (SNP) which can predict oxaliplatin-induced neuropathy |
| Date of disclosure of the study information | 2008/07/08 |
| Last modified on | 2010/04/26 16:23:55 |
* 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
Exploratory research to investigate the single nucleotide polymorphisms (SNP) which can predict oxaliplatin-induced neuropathy
Acronym
Oxaliplatin-induced neuropathy and SNP
Scientific Title
Exploratory research to investigate the single nucleotide polymorphisms (SNP) which can predict oxaliplatin-induced neuropathy
Scientific Title:Acronym
Oxaliplatin-induced neuropathy and SNP
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate the single nucleotide polymorphisms correlated with oxaliplatin-induced neuropathy
Basic objectives2
Others
Basic objectives -Others
To investigate the single nucleotide polymorphisms correlated with the efficacy of oxaliplatin-based chemotherapy
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To investigate the single nucleotide polymorphisms correlated with oxaliplatin-induced neuropathy
Key secondary outcomes
To investigate the single nucleotide polymorphisms correlated with the efficacy of oxaliplatin-based chemotherapy
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
Male and Female
Key inclusion criteria
1.Histologically confirmed colorectal cancer patients whose oxaliplatin-related neurotoxicity was evaluated based on DEB-NTC after 6 courses of treatment
2.Written informed consent
Key exclusion criteria
N/A
Target sample size
82
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi Kanai |
Organization
Kyoto University Hospital
Division name
Outpatient Oncology Unit
Zip code
Address
54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyoto University Hospital
Division name
Outpatient Oncology Unit
Zip code
Address
TEL
Homepage URL
kanai@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto Universtiy Hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for the Promotion of Science
Organization
Division
Category of Funding 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
| 2008 | Year | 07 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2008 | Year | 04 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
| 2009 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 09 | Month | 01 | Day |
Other
Other related information
To investigate the SNP which can predict oxaliplatin-induced neurotoxicity
Management information
Registered date
| 2008 | Year | 07 | Month | 07 | Day |
Last modified on
| 2010 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001435
