Gene Expression Profiling in Normal Tissue and Tumor Tissue From Patients With Colon Cancer That Has Spread to the Liver, Lungs, or Peritoneum

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00896753
First received: May 9, 2009
Last updated: June 27, 2012
Last verified: June 2012
  Purpose

RATIONALE: Studying the genes expressed in samples of tissue from patients with cancer may help doctors identify biomarkers related to cancer.

PURPOSE: This laboratory study is using gene expression profiling to evaluate normal tissue and tumor tissue from patients with colon cancer that has spread to the liver, lungs, or peritoneum.


Condition
Colorectal Cancer
Metastatic Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Gene Expression Profiling of Metastatic Colon Cancer (CCCWFU 89B03)

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • Gene expression changes that occur at each metastatic site (i.e., liver, lungs, and peritoneum) [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • Development of cell lines from primary colon tumors metastatic to the liver, lungs, or peritoneum [ Time Frame: day 1 ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: September 2003
Study Completion Date: May 2008
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts
patients with metastatic colon cancer

Detailed Description:

OBJECTIVES:

  • Evaluate gene expression profiles in normal and tumor tissue from patients with colon cancer metastatic to the liver, lungs, or peritoneum.
  • Establish cell lines from primary colon tumors metastatic to the liver, lungs, or peritoneum.
  • Determine the specific gene expression changes that result in the manifestation of the drug-resistant phenotype for each metastatic site.

OUTLINE: This is a pilot study.

Tumor and normal tissue collected during surgery are analyzed for gene expression profiling by cDNA microarray. Tissue is also analyzed for thymidylate synthase (TS) gene expression by quantitative PCR and for protein expression by western blot. Gene expression patterns are correlated with TS levels.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with metastatic colen cancer

Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of colon cancer metastatic to the liver, lungs, or peritoneum

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00896753

Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Study Chair: Perry Shen, MD Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT00896753     History of Changes
Other Study ID Numbers: CDR0000550060, CCCWFU-89B03, CCCWFU-BG03-403
Study First Received: May 9, 2009
Last Updated: June 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Comprehensive Cancer Center of Wake Forest University:
stage IV colon cancer
liver metastases
lung metastases
recurrent colon cancer

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on April 14, 2014