Flemish Prospective Clinical and Pathological Database for Urothelial Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Progression to MIBC
研究概览
简要总结
The goal of the Flemish Databank for Urothelial Cancer is to collect clinical and pathological data of patients treated for urothelial cancer (UC).
详细描述
The goal of this study is to enable the prospective collection of demographic, clinical, pathological and follow-up data of UC patients after signing informed consent. The specific usage of these prospectively collected clinical data will be described in future trials.
Templates for data collection, which also include clinical outcome parameters and quality indicators, were developed in InfoPath™ as an electronic case report form (eCRF) and were implemented within our hospital's electronic patient file system (called Klinisch Werkstation (KWS), which runs in different Flemish hospitals). These eCRFs have been developed based on the recommendations of the European Association of Urology (EAU) guidelines and the Canadian Urological Association (CUA) white paper. Three separate eCRFs were developed for the management of non-muscle-invasive bladder cancer (NMIBC) patients: surgery report, bladder instillation form, and multidisciplinary team (MDT) form. With the scientific output parameters and quality indicators based on the current knowledge, patient flow-charts for the diagnosis of bladder cancer, and management of low-, intermediate- and high-risk NMIBCs have been developed.
This databank will be first used to externally validate the European Organization for Research and Treatment of Cancer (EORTC) and the Club Urologico Español de Tratamiento Oncologico (CUETO) nomograms for recurrence and progression in patients with NMIBC who have been treated according to the state of the art and prospectively followed up. In-depth analysis of the data generated in this registry will give us the opportunity to define improvements in patient follow-up protocol. Moreover, based on this dataset, we aim to develop a risk calculator for disease recurrence and progression, which will be readily available for Flemish hospitals to use.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •who are aged between 18-90,
- •who are of male or female sex,
- •who give their informed consent to collect their clinical and pathological data,
- •who are planned to undergo TURBT for BC,
- •who are planned to undergo (salvage) radical cystectomy with or without an extended pelvic lymph node dissection,
- •who are planned to undergo tumor biopsy (from primary or metastatic tumor),
- •who are planned to undergo radical nephroureterectomy ± partial cystectomy or segmental ureterectomy, with or without a lymph node dissection,
- •who are planned to undergo endoscopic tumor biopsy or resection,
- •from whom metastases will be surgically removed.
排除标准
- •patients who do not give their informed consent to collect their clinical and pathological data,
- •patients who withdraw their informed consent to use their clinical and pathological data,
- •patients who refuse the planned treatment,
- •women who are pregnant or have suspicion of pregnancy.
结局指标
主要结局
Progression to MIBC
时间窗: 10 years
Histopathologically proven muscle-invasive bladder cancer (at least T2 disease) in pathological evaluation of the TURBT specimen
次要结局
- Recurrence of NMIBC(5 years)