NCT00172367撤回2 期
Chemoprevention Trial for Uremia-Associated Urothelial Carcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- changes of intermediate biomarker status after lycopene supplementation
研究概览
简要总结
Primary Objective: To study if lycopene can improve the biomarker status of urothelial cells in patients with uremia-associated urothelial carcinoma.
Secondary Objective: To evaluate the general safety and tolerability of oral lycopene 30 mg per day for 12 weeks in uremic patients.
详细描述
This is a renal function-stratified phase II chemoprevention trial. After 8 weeks of a run-in and washout period, participants will take lycopene, 30 mg per day for 12 weeks. The expression of intermediate biomarkers will be determined upon study entry after 8 weeks of run-in/washout, and after 6 and 12 weeks of lycopene supplementation. It takes at least 20 weeks to complete the course.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Patients have pathologically-proven urothelial carcinoma (UC) with a clinical stage <= T3N0M0
- •Patients have no visible or identifiable residual UC after treatment with a life expectancy of > 6 months
- •Patients have remaining urothelium at risk of recurrence (transplanted renal unit excluded)
- •No other active malignancy. Patients who have other primary malignancies should be treated successfully prior to the study entry and should be in a cure or remission state for at least one year.
- •Patients are able to take lycopene capsules orally.
- •Patients who sign and give informed consents and are willing to conform to the scheduled sampling of the blood, urine and/or tissue
排除标准
- •Patients who have clinical stage > T3N0M0 or metastatic disease
- •Positive urine cytology. Patients who have positive cytology should be subjected to a serial diagnostic workup which may include renal echo, cystoscopy and ureterorenoscopy, and image studies (intravenous urography, computed tomography, magnetic resonance urography, retrograde or antegrade pyelography). If no recurrent or residual tumors are found, patients are still eligible for the study.
- •Patients who have ever received systemic chemotherapy within 12 months
- •Patients who have gastrointestinal malabsorption regardless of the etiology
- •Have known allergic reaction to tomato or lycopene
- •Patients who are participating or will participate in other clinical trials
- •Patients who have active urinary tract infection can not be accrued until infection is effectively controlled
- •Patient's age is less than 18 years
结局指标
主要结局
changes of intermediate biomarker status after lycopene supplementation
次要结局
- safety and tolerability
研究者
研究点 (1)
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