In the Prediction of Recurrence and Progression of NMIBC; EORTC or CUETO or Both?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 主要终点
- Recurrence or progression
研究概览
简要总结
Investigators aimed to evaluate the performance of The European Organization for Research and Treatment of Cancer(EORTC) and the Spanish Urology Association for Oncological Treatment(CUETO) risk tables on all non-muscle invasive bladder cancer patients(NMIBC), and those not treated with BCG and treated with BCG separately.
详细描述
Risk tables can be used for the prediction of recurrence and especially progression of nonmuscle invasive bladder cancer .The European Organization for Research and Treatment of Cancer(EORTC) developed a risk table,which provides a scoring system for recurrence and progression risk.The EORTC risk table includes these factors: number of tumors,tumor size,prior recurrence rate,T stage,presence of carcinoma in situ(CIS),and grade for NMIBC patients not treated by maintenance bacillus Calmette-Guerin(BCG) instillation therapy.The Spanish Urology Association for Oncological Treatment(CUETO)later proposed a modified model to be used for patients only treated with BCG instillation.This risk table includes these factors:age,gender,recurrent tumor,number of tumors,T stage,CIS,and grade.
There is no risk table that can be used for NMIBC patients treated or not treated with BCG.Should we use the EORTC risk table for patients not treated with BCG and the CUETO table only for those treated with BCG or is one of them sufficient to predict recurrence and progression in all patients?The main aim of this study was to compare the utility of the EORTC and CUETO risk tables in all patients, and separately in patients not treated with BCG and treated with BCG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary or recurrent bladder cancer
- •non-muscle invasive bladder cancer
- •at least 60 months follow-up period if progression was not determined.
排除标准
- •primary CIS,
- •muscle-invasive disease after second look TUR-BT
- •non-urothelial carcinoma of the bladder,
- •concomitant upper urinary tract tumor,
- •not able to contacted for whatever reason
研究组 & 干预措施
Group 1
Whole patient group (patients not treated with BCG and patients treated with BCG)
干预措施: Intravesical BCG instillation (Procedure)
Group 2
Patients not treated with BCG
Group 3
Patients treated with BCG
干预措施: Intravesical BCG instillation (Procedure)
结局指标
主要结局
Recurrence or progression
时间窗: From date of participitant recruitment until the date of first documented progression or recurrence or death from any cause, whichever came first, assessed up to 60 months
The primary end point for recurrence was accepted as the occurrence of the first recurrence or progression
次要结局
未报告次要终点
研究者
Muhammet Fatih Kilinc
Principal investigator, Medical doctor
Ankara Training and Research Hospital