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Genes That Affect Disease Outcome in Patients With Metastatic Colorectal Cancer

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.
ClinicalTrials.gov Identifier: NCT00467129
Recruitment Status : Unknown
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : April 27, 2007
Last Update Posted : December 18, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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.

Condition or disease Intervention/treatment
Colorectal Cancer Genetic: microarray analysis Genetic: mutation analysis Genetic: polymerase chain reaction Genetic: polymorphism analysis Other: laboratory biomarker analysis Other: questionnaire administration

Detailed Description:


  • 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.

Study Type : Observational
Estimated Enrollment : 800 participants
Official Title: The Role of Genetic Factors in Clinical Outcome for Colorectal Cancer
Study Start Date : July 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Survival
  2. Progressive disease-free survival

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


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


  • Not Specified


  • See Disease Characteristics

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 ClinicalTrials.gov identifier (NCT number): NCT00467129

Sponsors and Collaborators
University of Sheffield
Study Chair: Angela Cox, PhD University of Sheffield

ClinicalTrials.gov Identifier: NCT00467129     History of Changes
Other Study ID Numbers: CDR0000540670
First Posted: April 27, 2007    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: May 2007

Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
stage IV rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases