Prospective and Multicenter Italian Registry of Locally Advanced-Metastatic Urothelial Carcinoma

Recruiting

• Conditions: Carcinoma, Urothelial

• Registration Number: NCT06235268
• Lead Sponsor: Federation of Italian Cooperative Oncology Groups

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.

Study Timeline

• Study Start: 2023-11-23
• Status Verified: 2024-01
• Study First Submitted: 2024-01-22
• Study First Submitted QC: 2024-01-30
• Last Update Submitted: 2024-01-30
• Study First Posted: 2024-01-31
• Last Update Posted: 2024-01-31
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 \[5.0\].
Progression free survival	up to 2 years	the time from assignment to treatment to disease progression or death from any cause
Treatment reality in Italy	over 2 years	description of treatments selected for patients per line of therapy over the course of the project
Overall survival	2 years	Survival from Diagnosis to time of death

Trial Locations

Locations (51)

Azienda Ospedaliera Universitaria delle Marche; 🇮🇹 Ancona, Italy

Azienda Ospedaliera per l'Emergenza Cannizzaro; 🇮🇹 Catania, Italy

Azienda Ospedaliera Papa Giovanni XXIII; 🇮🇹 Bergamo, Italy

Azienda Ospedaliera Universitaria Carreggi; 🇮🇹 Firenze, Italy

Casa della Salute, Aprilia; 🇮🇹 Latina, Italy

Ospedale Cardinal Massaia; 🇮🇹 Asti, Italy

Spedali Civili; 🇮🇹 Brescia, Italy

Centro Regionale Oncologico di Aviano; 🇮🇹 Aviano, Italy

Ospedale Villa Scassi ASL 3 Genova; 🇮🇹 Genova, Italy

MultiMedica Sesto san Giovanni; 🇮🇹 Milano, Italy

Ospedale San Paolo Savona; 🇮🇹 Savona, Italy

A.O Ordine Mauriziano; 🇮🇹 Torino, Italy

AULSS 8 Berica; 🇮🇹 Vicenza, Italy

Policlinico Universitario di Bari; 🇮🇹 Bari, Italy

Azienda Ospedaliera di Rilievo Nazionale Cardarelli; 🇮🇹 Napoli, Italy

Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"; 🇮🇹 Napoli, Italy

Azienda Ospedaliero-Universitaria Parma; 🇮🇹 Parma, Italy

Azienda Ospedaliera San Giovanni Addolorata; 🇮🇹 Roma, Italy

IRCCS Istituto Nazionale Tumori Regina Elena Roma; 🇮🇹 Roma, Italy

Azienda Ospedaliero-Universitaria Città della Salute e della Scienza; 🇮🇹 Torino, Italy

IRCCS Istituto Tumori Giovanni Paolo II; 🇮🇹 Bari, Italy

ASST Cremona; 🇮🇹 Cremona, Italy

Azienda Ospedaliero-Universitaria, Policlinico Riuniti; 🇮🇹 Foggia, Italy

Istituto Oncolgico Romagnolo di Meldola; 🇮🇹 Forlì, Italy

IRCCS Ospedale Policlinico San Martino; 🇮🇹 Genova, Italy

Ospedale Vito Fazzi; 🇮🇹 Lecce, Italy

ASST OVEST Milanese - Ospedale di Legnano; 🇮🇹 Legnano, Italy

Humanitas Research Hospital Rozzano; 🇮🇹 Milano, Italy

Istituto Europeo di Oncologia (IEO); 🇮🇹 Milano, Italy

IRCCS Fondazione istituto Nazionale dei Tumori; 🇮🇹 Milan, Italy

Ospedale Civile Ramazzini di Carpi; 🇮🇹 Modena, Italy

Azienda Ospedaliera Universitaria Federico II; 🇮🇹 Napoli, Italy

Azienda Ospedaliero-Universitaria Maggiore della Carità; 🇮🇹 Novara, Italy

IRCCS Istituto Oncologico Veneto IOV; 🇮🇹 Padova, Italy

Ospedali di Cittadella e Camposampiero, ULSS 6 Euganea; 🇮🇹 Padova, Italy

Presidio Ospedaliero Andrea Tortora di Pagani; 🇮🇹 Pagani, Italy

Azienda di rilievo nazionale e di Alta Specializzazione (ARNAS) Civico; 🇮🇹 Palermo, Italy

Fondazione IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Italy

Ospedali Riuniti Marche Nord; 🇮🇹 Pesaro, Italy

Azienda Ospedaliera Universitaria Pisana; 🇮🇹 Pisa, Italy

Nuovo Ospedale di Prato "Santo Stefano", Azienda USL Toscana Centro; 🇮🇹 Prato, Italy

Arcispedale S. Maria Nuova; 🇮🇹 Reggio Emilia, Italy

Azienda Ospedaliera San Camillo Forlanini; 🇮🇹 Roma, Italy

Ospedale Santa Maria Goretti; 🇮🇹 Roma, Italy

IRCCS Casa Sollievo della Sofferenza - San Giovanni Rotondo; 🇮🇹 San Giovanni Rotondo, Italy

Azienda Ospedaliera Santa Maria di Terni; 🇮🇹 Terni, Italy

IRCCS Fondazione del Piemonte per l'Oncologia Candiolo; 🇮🇹 Torino, Italy

Ospedale S. Chiara; 🇮🇹 Trento, Italy

Azienda Sanitaria Universitaria Friuli Centrale - Ospedale "Santa Maria della Misericordia"; 🇮🇹 Udine, Italy

Ospedale Michele e Pietro Ferrero, ASL CN2; 🇮🇹 Verduno, Italy

Policlinico Universitario Campus Bio-Medico; 🇮🇹 Roma, Italy