Prospective and Multicenter Italian Registry of Locally Advanced-Metastatic Urothelial Carcinoma (Saturno Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 51
- 主要终点
- Toxicities
研究概览
简要总结
Prospective and multicenter Italian registry intended for naïve adult patients affected by locally advanced-metastatic urothelial carcinoma intended for systemic treatment, or for palliative or observation procedures
详细描述
This is a multicentre, prospective and non-interventional study in which all patients treated according to clinical practice will be included. The registry will include all patients with metastatic urothelial carcinoma or with lymph node involvement defined as unsuitable for surgery. The study involves medical visits and clinical-radiological re-evaluations according to clinical practice. There are no additional procedures. The clinician will establish the number of visits necessary for each patient according to the needs encountered and depending on the treatment chosen. The participating centers were selected in such a way as to adequately represent all the different geographical areas. The duration of the study is 24 months: 12 months of enrollment plus 12 months of further follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cytological and/or histological diagnosis of urothelial carcinoma or at least with one urothelial component originating from the genitourinary tract.
- •Radiological diagnosis of metastatic or locally advanced disease inoperable
- •Primary bladder, ureter, renal pelvis and of the urethra are included
- •No previous chemotherapy for advanced urothelial carcinoma or metastatic disease
- •Age over 18 years old
- •Ability to understand and sign the informed consent
- •Patients for whom the clinician has opted for a therapeutic path not including active systemic treatments (iter palliative or observation) with certain diagnosis of metastatic disease
- •Patients with lymph node extension of the disease who are not candidates to neoadjuvant treatment
- •Any ECOG PS and therapeutic management is permitted.
- •Previous surgeries and antineoplastic treatments are permitted as long as not carried out for metastatic disease (adjuvant and/or neoadjuvant)
排除标准
- •Patients who have received previous systemic treatment for metastatic disease
- •Patients with histological and/or cytological diagnosis without urothelial component
- •Patients with muscle-infiltrating disease without evidence of metastatic disease
- •Patients with non-muscle infiltrating disease without evidence of metastatic disease
结局指标
主要结局
Toxicities
时间窗: up to 2 years
Safety parameters commonly used for evaluating investigational systemic anticancer treatments are included as safety endpoints including, but not limited to, the incidence of, causality, and outcome of AEs/SAEs; and changes in vital signs and laboratory values. AEs will be assessed as defined by CTCAE, Version \[5.0\].
Progression free survival
时间窗: up to 2 years
the time from assignment to treatment to disease progression or death from any cause
Treatment reality in Italy
时间窗: over 2 years
description of treatments selected for patients per line of therapy over the course of the project
Overall survival
时间窗: 2 years
Survival from Diagnosis to time of death
次要结局
未报告次要终点