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

University of Arkansas44 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Colon Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Outcomes

Primary Outcomes

Compare the prognosis of colon cancer patients compared to gene expression.

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

Time frame: 1 year

Data from ClinicalTrials.gov

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