Registry for Treatment of Upper Urinary Tract Tumours; A Multi-Center, International Registry to Evaluate the Treatment of Upper Tract Urothelial Cancer: Incidence, Indications, Treatment Types and Outcomes.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,451
- 试验地点
- 1
- 主要终点
- Recurrence rates for patients presenting with primary UTUC stratified for type of treatment
研究概览
简要总结
The aim of this registry is to evaluate the incidence, indications and outcomes of patients presenting with UTUC in relation to the different treatment modalities used.
详细描述
This is an observational international multi-center study in which data on consecutive patients with UUT tumours are collected. Centers from every continent may apply for participation in this registry. Data will be collected from consecutive patients over a five year period. Patients' data at baseline visit, at one year, three years and five years after inclusion in the registry will be recorded, as well as data on intra- and postoperative complications, recurrence and survival in the whole study period. Data from all participating centers will be collected through electronic case report forms (eCRFs), with use of an online Data Management System (DMS), which is located and maintained at the CROES Office.
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
- — 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is presenting with a suspected primary UTUC (any stage)
- •Is scheduled for treatment of UUT tumour
- •Has signed informed consent
排除标准
- •No specific exclusion criteria are defined.
结局指标
主要结局
Recurrence rates for patients presenting with primary UTUC stratified for type of treatment
时间窗: 10 years
Data collection will be divided into the following categories: Patient / tumour characteristics, assessment, treatment choice and intra-operative details, post-operative details and complications, and follow up. The following lists all categories and type of data to be gathered. Patient characteristics: demographics, risk factors, comorbidities and previous malignancies. Assessment: symptoms, imaging type, cytology, TNM staging. Treatment choice and intra-operative details: date, use of endoscopy, type of scopes, type of imaging enhancement, biopsies, results, neo adjuvant treatment specifications and treatment type. Intra-operative: date, duration, antibiotics, type of treatment, results. Post-operative: complications and Clavien-Dindo classification, instillation, adjuvant therapy, pathology. Follow up: date, status (e.g. alive without cancer, alive with cancer), recurrence, diagnostics performed, cystoscopy, cytology, results.
次要结局
- Intra- and postoperative complications (including Clavien-Dindo classification)(5 years)