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
  Purpose

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
Colon Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • 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


Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 50
Study Start Date: November 2011
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT01479894

Contacts
Contact: Rangwasmy Govindarajan, MD 501-686-8511 GovindarajanRang@uams.edu
Contact: Cynthia L Walton 501-686-8274 waltoncynthial@uams.edu

Locations
United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72120
Contact: Rangaswamy Govindarajan, MD    501-686-8511    govindarajanrang@uams.edu   
Contact: Cynthia L Walton    5016868274    waltoncynthial@uams.edu   
Principal Investigator: Rangaswamy Govindarajan, MD         
Sponsors and Collaborators
University of Arkansas
Genomic Health
  More Information

No publications provided

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01479894     History of Changes
Other Study ID Numbers: 133972
Study First Received: November 17, 2011
Last Updated: September 16, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 21, 2014