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

Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01479894
• Other study ID #: 133972
• Status: Completed
• Start date: November 2011
• Est. completion date: January 2015

Study information

• Verified date: February 2015
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Arkansas	Genomic Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year