Prediction of Impaired Survival in Elderly Bladder Cancer Patients Opting for 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
- Impairment Free Survival
研究概览
简要总结
The investigators proposes a prospective cohort study in patients with high risk bladder cancer who have opted for radical cystectomy. The investigators aim to correlate pre-operative measures of body composition, cognitive and functional status with impaired survival at 6 months after cystectomy. Impairment in this context will be a compilation of several specific objective measures including: 1) death from any cause, 2) major complication (Clavien score7 ≥ 3), 3) loss of independent living status, 4) performance status, and 5) global well-being. The study team believes that Impairment Free Survival is an important endpoint as it accounts for many aspects of a patient's functional status that might alter a patient's choice to proceed with radical surgery.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic diagnosis of bladder carcinoma (any histology permitted)
- •Planned treatment with radical cystectomy.
- •Age 65 years or older at the time of radical cystectomy
- •Able to give consent
- •Neoadjuvant chemotherapy is permissible
- •Prior malignancy is permissible, without evidence of disease for at least 2 years
- •Concomitant localized prostate cancer, skin cancer, and in situ malignancies are permissible.
- •Willingness to complete surgical follow-up at the University of Michigan for at least 6 months after radical cystectomy.
排除标准
- •Evidence of metastatic bladder cancer
- •Life expectancy less than one year
- •Concurrent treatment on another clinical trial. Non-intervention supportive care trials or non-treatment trials, e.g. QOL, are allowed
结局指标
主要结局
Impairment Free Survival
时间窗: 6 months
Impairment-free survival is defined as the time from radical cystectomy to the identification of: 1) major complication (Clavien score7 ≥ 3), 2) loss of independent living status, 3) ECOG performance status ≥ 3 beyond 4 weeks from RC, 4) global well-being or 5) death from any cause. Patients who drop-out before the 6-month end of study and who have not had an impairment event will be censored at their time of drop-out.
次要结局
未报告次要终点