Carcinoma, Urothelial
Conditions
Brief summary
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
Detailed description
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.
Interventions
OTHERActive systemic or non-systemic treatment (palliative or observation procedure)
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.
Sponsors
Federation of Italian Cooperative Oncology Groups
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 2 years | Survival from Diagnosis to time of death |
| Progression free survival | up to 2 years | the time from assignment to treatment to disease progression or death from any cause |
| Toxicities | 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 \[5.0\]. |
| Treatment reality in Italy | over 2 years | description of treatments selected for patients per line of therapy over the course of the project |
Countries
Italy
Contacts
Primary ContactGiuseppe Procopio
Backup ContactMarco Stellato
Outcome results
None listed