Detection and Clinical Significance of Circulating Cancer Cells in Patient Undergoing Radical Cystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Prevalence of circulating tumor cells
研究概览
简要总结
Very few factors may be identified as prognostic for patients with bladder cancer undergoing radical cystectomy. Recently, detection of circulating tumor cells has shown to be very promising in anticipating both the likelyhood of distant metastases and survival in patients with breast cancer, melanoma, prostate cancer and other malignancies. In the present study we both tested the detection rate of circulating tumor cells using a PCR based methodology in the peripheral blood of patients undergoing radical cystectomy, and we further correlated our results with their clinical outcome.
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
- 是
入选标准
- •Prior trans urethral resection of the bladder (TUR)
- •Histological confirmation of a transitional cell carcinoma (TCC) of the bladder
- •ECOG Performance Status ≤ 2
- •WBC count ≥4,000/μL; platelet count ≥150,000/μL; creatinine ≤1.8 mg/dL; AST, ALT, and alkaline phosphatase ≤2X the upper limit of normal, normal total bilirubin
- •recent (within 6 weeks of cystectomy) total body CT imaging study excluding distant metastases as well as upper urinary tract TCC
排除标准
- •Neo-adjuvant chemotherapy (either planned or already performed)
- •Patients receiving investigational medications
- •Subjects not suitable for a radical cystectomy
- •Patients not willing to participate
结局指标
主要结局
Prevalence of circulating tumor cells
时间窗: 8 years
This outcome measure reflects the exact number of subjects diagnosed with circulating tumor cells within the total population of subjects included in the study
次要结局
- Overall survival(8 years)
研究者
Pagliarulo Vincenzo
Medical Doctor
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari