This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Genes That Affect Disease Outcome in Patients With Metastatic Colorectal Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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
  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:


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

Primary Outcome Measures:
  • Survival
  • Progressive disease-free survival

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

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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: December 17, 2013

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 September 21, 2017