Genes That Affect Disease Outcome in Patients With Metastatic Colorectal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00467129
First received: April 25, 2007
Last updated: December 17, 2013
Last verified: May 2007

April 25, 2007
December 17, 2013
July 2002
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  • Survival [ Designated as safety issue: No ]
  • Progressive disease-free survival [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00467129 on ClinicalTrials.gov Archive Site
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Genes That Affect Disease Outcome in Patients With Metastatic Colorectal Cancer
The Role of Genetic Factors in Clinical Outcome for Colorectal Cancer

RATIONALE: Studying samples of blood and tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and help doctors understand how patients respond to treatment.

PURPOSE: This clinical trial is examining genes that affect disease outcome in patients with metastatic colorectal cancer.

OBJECTIVES:

  • Collect blood samples for DNA extraction for genetic studies from patients receiving chemotherapy for metastatic colorectal cancer.
  • Collect detailed clinical, pathological, and chemotherapy data from these patients.
  • Identify genetic factors that relate to treatment response and outcome in these patients.

OUTLINE: Blood samples are collected and relevant genes and regions are amplified by PCR. PCR products are then sequenced or genotyped for known biological markers and single nucleotide polymorphisms. Tumor samples from surplus pathology specimens are analyzed for expression of candidate genes and mutation in the candidate genes.

Clinical and family history data is also collected by questionnaire.

PROJECTED ACCRUAL: A total of 800 patients will be accrued for this study.

Observational
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Colorectal Cancer
  • Genetic: microarray analysis
  • Genetic: mutation analysis
  • Genetic: polymerase chain reaction
  • Genetic: polymorphism analysis
  • Other: laboratory biomarker analysis
  • Other: questionnaire administration
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
800
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DISEASE CHARACTERISTICS:

  • Diagnosis of metastatic colorectal cancer
  • Currently receiving chemotherapy at Weston Park Hospital

PATIENT CHARACTERISTICS:

  • Not Specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT00467129
CDR0000540670, SHEFF-SSREC01/271, SHEFF-USMS-SSREC01/271, EU-20727
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University of Sheffield
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Study Chair: Angela Cox, PhD University of Sheffield
National Cancer Institute (NCI)
May 2007

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