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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01479894

Enrollment

Registered

2011-11-28

Start date

2011-11-30

Completion date

2015-01-31

Last updated

2021-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Compare the prognosis of colon cancer patients compared to gene expression.	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

Countries

United States

Outcome results