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

September 3, 2009
April 15, 2010
September 2008
January 2010   (final data collection date for primary outcome measure)
neuropathy [ Time Frame: six months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00977717 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pharmacogenomic Study to Predict Neurotoxicity of Oxaliplatin
Pharmacogenomic Study to Predict Toxicity and Response in Colorectal Cancer Patients Treated With Oxaliplatin-based Chemotherapy

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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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

Non-Probability Sample

Curatively resected stage III colon cancer

Curatively Resected Stage III Colon Cancer
Not Provided
FOLFOX
Stage III colorectal cancer patients who are treated with adjuvant FOLFOX chemotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
April 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00977717
2008-05-052
No
Se Hoon Park, MD, Samsung Medical Center, Seoul, Korea
Samsung Medical Center
Not Provided
Principal Investigator: Se Hoon Park, MD Samsung Medical Center, Seoul, Korea
Samsung Medical Center
April 2010

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