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OpenTrials
Completed

NCT Number: NCT01479894

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

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.

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72120, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Collaborators

  • Genomic Health

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Nov 28, 2011
Registry last updated
Aug 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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