Genetic Analysis to Evaluate the Racial Difference in the Outcome of Patients With Colon Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Compare the prognosis of colon cancer patients compared to gene expression.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Compare the prognosis of colon cancer patients compared to gene expression.
时间窗: 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
次要结局
未报告次要终点