Genetic Analysis to Evaluate the Racial Difference in the Outcome of Patients With Colon Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of Arkansas
Sponsor:
Collaborator:
Genomic Health
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01479894
First received: November 17, 2011
Last updated: September 16, 2014
Last verified: September 2014

November 17, 2011
September 16, 2014
November 2011
December 2014   (final data collection date for primary outcome measure)
Compare the prognosis of colon cancer patients compared to gene expression. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01479894 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Genetic Analysis to Evaluate the Racial Difference in the Outcome of Patients With Colon Cancer
Not Provided

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:

The Oncotype DX Colon Cancer Assay will be utilized to define the gene expression profile of the tumor tissue.

Probability Sample

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.

Colon Cancer
Not Provided
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
Not Provided
December 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Rangwasmy Govindarajan, MD 501-686-8511 GovindarajanRang@uams.edu
Contact: Cynthia L Walton 501-686-8274 waltoncynthial@uams.edu
United States
 
NCT01479894
133972
No
University of Arkansas
University of Arkansas
Genomic Health
Not Provided
University of Arkansas
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP