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
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.
Study Type
OBSERVATIONAL
Enrollment
1,000
The study includes medical visits and clinical-radiological re-evaluations according to clinical practice. The clinician will establish the number of visits necessary for each patient according to the needs encountered and depending on the treatment chosen.
Overall survival
Survival from Diagnosis to time of death
Time frame: 2 years
Progression free survival
the time from assignment to treatment to disease progression or death from any cause
Time frame: up to 2 years
Toxicities
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 \[5.0\].
Time frame: up to 2 years
Treatment reality in Italy
description of treatments selected for patients per line of therapy over the course of the project
Time frame: over 2 years
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Azienda Ospedaliera Universitaria delle Marche
Ancona, Italy
NOT_YET_RECRUITINGOspedale Cardinal Massaia
Asti, Italy
NOT_YET_RECRUITINGCentro Regionale Oncologico di Aviano
Aviano, Italy
NOT_YET_RECRUITINGIRCCS Istituto Tumori Giovanni Paolo II
Bari, Italy
NOT_YET_RECRUITINGPoliclinico Universitario di Bari
Bari, Italy
NOT_YET_RECRUITINGAzienda Ospedaliera Papa Giovanni XXIII
Bergamo, Italy
NOT_YET_RECRUITINGSpedali Civili
Brescia, Italy
NOT_YET_RECRUITINGAzienda Ospedaliera per l'Emergenza Cannizzaro
Catania, Italy
NOT_YET_RECRUITINGASST Cremona
Cremona, Italy
NOT_YET_RECRUITINGAzienda Ospedaliera Universitaria Carreggi
Florence, Italy
NOT_YET_RECRUITING...and 42 more locations