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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
  Purpose

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


Condition
Curatively Resected Stage III Colon Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacogenomic Study to Predict Toxicity and Response in Colorectal Cancer Patients Treated With Oxaliplatin-based Chemotherapy

Resource links provided by NLM:

Drug Information available for: Oxaliplatin
U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • neuropathy [ Time Frame: six months ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 100
Study Start Date: September 2008
Study Completion Date: April 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
FOLFOX
Stage III colorectal cancer patients who are treated with adjuvant FOLFOX chemotherapy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Curatively resected stage III colon cancer

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00977717

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

No publications provided

Responsible Party: Se Hoon Park, MD, Samsung Medical Center, Seoul, Korea
ClinicalTrials.gov Identifier: NCT00977717     History of Changes
Other Study ID Numbers: 2008-05-052
Study First Received: September 3, 2009
Last Updated: April 15, 2010
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Samsung Medical Center:
oxaliplatin
neuropathy
SNPs

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
 Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Oxaliplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013