We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Genetic Analysis to Evaluate the Racial Difference in the Outcome of Patients With Colon 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: NCT01479894
Recruitment Status : Completed
First Posted : November 28, 2011
Last Update Posted : February 19, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a retrospective genetic analysis of stored tumor tissue samples to evaluate the distribution of Recurrence Score® and gene groups of stage II colon cancer in African American (AA) and Caucasian individuals. Other covariant factors in the medical chart will be analyzed as well. Three institutions will contribute patients to this study with a total patient number goal of approximately 200 with approximately 100 being AA and approximately 100 being Caucasian. As enrollment in this study proceeds a Caucasian subject will be matched for every African American enrolled.

Condition or disease
Colon Cancer

Study Design

Study Type : Observational
Actual Enrollment : 44 participants
Observational Model: Cohort
Time Perspective: Retrospective
Study Start Date : November 2011
Primary Completion Date : January 2015
Study Completion Date : January 2015
Groups and Cohorts

Group/Cohort
Sample Collection
This is an exploratory study utilizing archived tumor specimens and demographic and pathologic characteristics derived from the patient's medical charts. As such, all eligible patients must have a stored tumor specimen which can be accessed for analysis.


Outcome Measures

Primary Outcome Measures :
  1. Compare the prognosis of colon cancer patients compared to gene expression. [ Time Frame: 1 year ]
    Compare the values of the Recurrence Score and expression levels of gene groups and individual genes between African Americans and Caucasians with Stage II colon cancer


Biospecimen Retention:   Samples With DNA
The Oncotype DX Colon Cancer Assay will be utilized to define the gene expression profile of the tumor tissue.

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This is an exploratory study utilizing archived tumor specimens and demographic and pathologic characteristics derived from the patient's medical charts. As such, all eligible patients must have a stored tumor specimen which can be accessed for analysis.
Criteria

Inclusion Criteria:

  • Subjects must be 18 years of age or older.
  • Subjects must be AA or Caucasian.
  • Subjects with pathologic stage II colon cancer; Irrespective of number of nodes examined.

Exclusion Criteria:

  • Patients of races other than AA or Caucasian.
  • No tumor block available from initial diagnosis.
  • No tumor or very little tumor (<5% tumor present) in block as assessed by examination of the H&E slide by the Genomic Health, Inc (GHI) - designated pathologist.
  • Tumor types other than adenocarcinoma NOS (not otherwise specified) and mucinous carcinoma as assessed by examination of the H&E slide by the GHI-designated pathologist.
  • Insufficient RNA (<5 ng/μL or 300 ng) for RT-PCR (radiation therapy - pathologic complete response) analysis.
  • Failure of assay to meet pre-specified quality control (QC) specifications.
Contacts and Locations

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): NCT01479894


Locations
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72120
Sponsors and Collaborators
University of Arkansas
Genomic Health
More Information

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01479894     History of Changes
Other Study ID Numbers: 133972
First Posted: November 28, 2011    Key Record Dates
Last Update Posted: February 19, 2015
Last Verified: February 2015

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