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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000002490
Receipt No. R000003053
Scientific Title Pharmacogenetic analysis to investigate the association between efficacy and neurotoxicity of oxaliplatin and single nucleotide polymorphisms
Date of disclosure of the study information 2009/11/10
Last modified on 2011/09/14

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Basic information
Public title Pharmacogenetic analysis to investigate the association between efficacy and neurotoxicity of oxaliplatin and single nucleotide polymorphisms
Acronym Pharmacogenetic analysis of oxaliplatin
Scientific Title Pharmacogenetic analysis to investigate the association between efficacy and neurotoxicity of oxaliplatin and single nucleotide polymorphisms
Scientific Title:Acronym Pharmacogenetic analysis of oxaliplatin
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 association between the efficacy of oxaliplatin for liver metastasis and SNP of ERCC1-118 in colorectal cancer patients.
Basic objectives2 Others
Basic objectives -Others To investigate the association between the oxaliplatin-induced neurotoxicity and SNP of GSTP1-105.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes To investigate the association between the efficacy of oxaliplatin for liver metastasis and SNP of ERCC1-118 in colorectal cancer patients.
Key secondary outcomes To investigate the association between the oxaliplatin-induced neurotoxicity and SNP of GSTP1-105.

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 with measurable liver metastasis who received oxaliplatin-based chemotherapy as first line treatment

2. Written informed consent is provided
Key exclusion criteria The patients with a history of adjuvant chemotherapy using oxaliplatin
Target sample size 133

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 075-751-4770
Homepage URL
Email

Sponsor
Institute Kyoto University 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 京都大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2009 Year 11 Month 10 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 Enrolling by invitation
Date of protocol fixation
2009 Year 09 Month 14 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2014 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Pharmacogenetic analysis of oxaliplatin

Management information
Registered date
2009 Year 09 Month 14 Day
Last modified on
2011 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003053

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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