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

NCT01479894 | Completed

• 1 other identifier: 133972
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arkansas: lead
• Genomic Health: collaborator

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72120, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2011
• First Posted: November 28, 2011
• Study Start: November 1, 2011
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: August 5, 2021

Record last verified: 2015-02

Locations

US (1)