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

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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 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


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

Value
https://center6.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