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临床试验/NCT00729287
NCT00729287已完成3 期

Phase III Randomized Chemoprevention Study of Selenium on the Recurrence of Non-invasive Bladder Cancer

KU Leuven2 个研究点 分布在 1 个国家目标入组 276 人开始时间: 2009年9月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
KU Leuven
入组人数
276
试验地点
2
主要终点
Effect of selenium in preventing the recurrence of bladder cancer

研究概览

简要总结

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of selenium may keep bladder cancer from growing or coming back. It is not yet known whether selenium is more effective than a placebo in preventing cancer recurrence in patients with bladder cancer.

PURPOSE: This randomized phase III trial is studying selenium to see how well it works compared with a placebo in preventing cancer recurrence in patients with bladder cancer.

详细描述

OBJECTIVES:

Primary

  • To determine the effect of selenium, when administered with standard care, in preventing the recurrence of bladder cancer in patients with non-muscle-invasive transitional cell carcinoma of the bladder at risk for recurrence.

Secondary

  • To determine the effect of selenium on the recurrence of bladder cancer, in terms of histological type, number, and size.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Effect of selenium in preventing the recurrence of bladder cancer

时间窗: 3 years

次要结局

  • Effect of selenium on the progression of bladder cancer, in terms of histological type, number, and size(3 years)

研究者

发起方
KU Leuven
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Goossens

Prof. dr. Frank Buntinx

KU Leuven

研究点 (2)

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