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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: February 14, 2009
Last verified: May 2007
History of Changes
  Purpose

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 Intervention
Colorectal Cancer
 Genetic: microarray analysis
Genetic: mutation analysis
Genetic: polymerase chain reaction
Genetic: polymorphism analysis
Other: laboratory biomarker analysis
Other: questionnaire administration

Study Type: Observational
Official Title: The Role of Genetic Factors in Clinical Outcome for Colorectal Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Survival [ Designated as safety issue: No ]
  • Progressive disease-free survival [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: July 2002
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

  • Not Specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00467129

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

No publications provided

ClinicalTrials.gov Identifier: NCT00467129     History of Changes
Other Study ID Numbers: CDR0000540670, SHEFF-SSREC01/271, SHEFF-USMS-SSREC01/271, EU-20727
Study First Received: April 25, 2007
Last Updated: February 14, 2009
Health Authority: United States: Federal Government

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
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on June 17, 2013