Thymidylate Synthase Polymorphisms as a Predictor of Toxicity to 5-Fluorouracil Based Chemotherapy in Stage III Colon Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 104
- 试验地点
- 1
研究概览
简要总结
Cancer of the colon and rectum are the third most common cancers in Canadian males and females. The initial therapy of colorectal cancer is surgery to remove the cancer and nearby lymph glands. If the cancer has spread to the lymph glands there is a high chance that the cancer will come back. To reduce the risk of the cancer recurring, patients are treated with an anticancer drug 5-fluorouracil (5FU) in combination with a vitamin leucovorin (LV). This study will determine if a simple blood test can predict which patients are at risk for developing side effects from this chemotherapy. In addition, participants of this study will be followed to determine if this same blood test will predict which patients will have their cancer relapse.
详细描述
Hypothesis:
Recently, the thymidylate synthase gene's promoter has been found to be polymorphic, with variable numbers of tandem repeats of 28 base pairs in length. These polymorphisms have been associated with tumor response to treatment with fluoropyrimidines. The researchers hypothesize that polymorphisms in thymidylate synthase (TS) gene's promoter region are associated with toxicity from 5-fluorouracil (5FU)/leucovorin (LV) treatment specifically development of myelosuppression and diarrhea. The researchers hypothesize that a polymorphism in methylene tetrahydrofolate reductase (MTHFR) is also associated with toxicity and efficacy of 5FU/LV treatment. The researchers speculate that the MTHFR polymorphism only becomes clinically significant by stratifying patients by TS promoter polymorphisms.
Objectives:
- To determine if polymorphisms in thymidylate synthase's promoter region are associated with development of overall toxicity, diarrhea, neutropenia, or mucositis in patients treated with 5FU/LV.
- To determine if a polymorphism in methylene tetrahydrofolate reductase (MTHFR) is associated with development of overall toxicity, diarrhea, neutropenia, or mucositis in patients treated with 5FU/LV
Background and Significance:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •To be treated with 5FU/LV
排除标准
- •Abnormal liver or kidney function