Pharmacogenomic Study to Predict Neurotoxicity of Oxaliplatin

This study has been completed.

Sponsor:

Information provided by:

Samsung Medical Center

ClinicalTrials.gov Identifier:

NCT00977717

First received: September 3, 2009

Last updated: April 15, 2010

Last verified: April 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

September 3, 2009

Last Updated Date

April 15, 2010

Start Date ^ICMJE

September 2008

Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

neuropathy [ Time Frame: six months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00977717 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Pharmacogenomic Study to Predict Neurotoxicity of Oxaliplatin

Official Title ^ICMJE

Pharmacogenomic Study to Predict Toxicity and Response in Colorectal Cancer Patients Treated With Oxaliplatin-based Chemotherapy

Brief Summary

In order to explore genetic factors that may determine the neurotoxicity of oxaliplatin-based chemotherapy, germinal gene polymorphisms will be analyzed.

Detailed Description

To investigate the impact of single nucleotide (SNP) polymorphism on the toxicity profile in colorectal cancer patients treated with FOLFOX chemotherapy, 10 cc of blood will be drawn in EDTA tube for extraction. DNA will be extracted from peripheral blood samples using DNA isolation kit, and SNP polymorphisms will be evaluated.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

DNA will be extracted from peripheral blood samples using DNA isolation kit.

Sampling Method

Non-Probability Sample

Study Population

Curatively resected stage III colon cancer

Condition ^ICMJE

Curatively Resected Stage III Colon Cancer

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

FOLFOX

Stage III colorectal cancer patients who are treated with adjuvant FOLFOX chemotherapy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

100

Completion Date

April 2010

Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

aged 18 or older
curatively resected colon adenocarcinoma
pathologically staged III
adequate performance status
adequate major organ functions
to be treated with adjuvant FOLFOX chemotherapy
written informed consent

Exclusion Criteria:

those who disagree the study

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT00977717

Other Study ID Numbers ^ICMJE

2008-05-052

Has Data Monitoring Committee

Responsible Party

Se Hoon Park, MD, Samsung Medical Center, Seoul, Korea

Study Sponsor ^ICMJE

Samsung Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Se Hoon Park, MD

Samsung Medical Center, Seoul, Korea

Information Provided By

Samsung Medical Center

Verification Date

April 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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