The Effect of Treatment on Circulating Tumor Cells in Bladder Cancer Patients With Muscle-invasive or Advanced Disease
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
- Effect of therapy
研究概览
简要总结
The investigators hypothesize that circulating tumor cells (CTC) will be observed in patients with muscle-invasive or metastatic bladder cancer and that CTC will become undetectable, at least transiently, in a fraction of patients after treatment. To investigate this hypothesis, investigators will assess the levels of CTCs both before and after treatment. The feasibility and potential value of fluorescent in situ hybridization (FISH) in the CTCs will be assessed.
详细描述
The measurement of circulating tumor cells is pursued in several cancers including breast and prostate cancer. The number of cells measured in these cancers has been shown to be prognostic. There is little information on the presence or importance of circulating tumor cells in bladder cancer. This trial is designed to determine if patients with advanced bladder cancer have circulating tumor cells and if these circulating cells are affected by treatment of the cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Pathological diagnosis of transitional cell carcinoma of the urothelium of at least T2-4, Nx, Mx stage. Mixed histologies will be allowed (e.g. squamous differentiation) as long as a transitional cell component is present.
- •Clinical plans for surgery (with or without chemotherapy), radiation therapy, or chemotherapy.
- •Participants must not have any condition which in the investigator's opinion may compromise the feasibility of completing the study.
- •Subject must be 18 years of age or older
- •Subject must be willing to have up to 4 peripheral blood samples obtained over a 6 month period of study.
- •Prior therapies for bladder cancer will be allowed if patient currently has muscle-invasive or metastatic bladder cancer despite the previous treatments.
- •Predicted life expectancy of > 12 weeks.
排除标准
- •Subjects who are unwilling or unable to comply with the study guidelines as determined by the principal investigator.
结局指标
主要结局
Effect of therapy
时间窗: baseline and then every 2 months
To determine the effect of therapy (cystectomy or chemotherapy) on circulating tumor cell (CTC) levels in bladder cancer patients.
次要结局
- Correlation between CTC levels and clinical outcome(baseline and then every 2 months)
- Presence of baseline CTC(baseline and then every 2 months)
- Assessing insulin like growth factor(baseline and then every 2 months)