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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001231
Receipt No. 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

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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
Email

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
Email kanai@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto Universtiy Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001435

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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