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Pharmacogenomic Study to Predict Neurotoxicity of Oxaliplatin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00977717
Recruitment Status : Completed
First Posted : September 16, 2009
Last Update Posted : April 19, 2010
Information provided by:
Samsung Medical Center

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

Condition or disease
Curatively Resected Stage III Colon Cancer

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacogenomic Study to Predict Toxicity and Response in Colorectal Cancer Patients Treated With Oxaliplatin-based Chemotherapy
Study Start Date : September 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin

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

Primary Outcome Measures :
  1. neuropathy [ Time Frame: six months ]

Biospecimen Retention:   Samples With DNA
DNA will be extracted from peripheral blood samples using DNA isolation kit.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Curatively resected stage III colon cancer

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00977717

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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135 710
Sponsors and Collaborators
Samsung Medical Center
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Principal Investigator: Se Hoon Park, MD Samsung Medical Center, Seoul, Korea

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Se Hoon Park, MD, Samsung Medical Center, Seoul, Korea Identifier: NCT00977717    
Other Study ID Numbers: 2008-05-052
First Posted: September 16, 2009    Key Record Dates
Last Update Posted: April 19, 2010
Last Verified: April 2010
Keywords provided by Samsung Medical Center:
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases