Clinical trial NCT06235268: Prospective and Multicenter Italian Registry of Locally Advanced-Metastatic Urothelial Carcinoma
Official title: Prospective and Multicenter Italian Registry of Locally Advanced-Metastatic Urothelial Carcinoma (Saturno Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carcinoma, Urothelial
Lead sponsor: Federation of Italian Cooperative Oncology Groups
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The registry will include all patients with metastatic urothelial carcinoma or with lymph node involvement defined as unsuitable for surgery.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: 2 years
measure: Progression free survival
timeFrame: up to 2 years
measure: Toxicities
timeFrame: up to 2 years
measure: Treatment reality in Italy
timeFrame: over 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Azienda Ospedaliera Universitaria delle Marche
city: Asti
country: Italy
facility: Ospedale Cardinal Massaia
city: Aviano
country: Italy
facility: Centro Regionale Oncologico di Aviano
city: Bari
country: Italy
facility: IRCCS Istituto Tumori Giovanni Paolo II
city: Bari
country: Italy
facility: Policlinico Universitario di Bari
city: Bergamo
country: Italy
facility: Azienda Ospedaliera Papa Giovanni XXIII
city: Brescia
country: Italy
facility: Spedali Civili
city: Catania
country: Italy
facility: Azienda Ospedaliera per l'Emergenza Cannizzaro
city: Cremona
country: Italy
facility: ASST Cremona
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Carreggi
city: Foggia
country: Italy
facility: Azienda Ospedaliero-Universitaria, Policlinico Riuniti
city: Forlì
country: Italy
facility: Istituto Oncolgico Romagnolo di Meldola
city: Genova
country: Italy
facility: IRCCS Ospedale Policlinico San Martino
city: Genova
country: Italy
facility: Ospedale Villa Scassi ASL 3 Genova
city: Latina
country: Italy
facility: Casa della Salute, Aprilia
city: Lecce
country: Italy
facility: Ospedale Vito Fazzi
city: Legnano
country: Italy
facility: ASST OVEST Milanese - Ospedale di Legnano
city: Milano
country: Italy
facility: Humanitas Research Hospital Rozzano
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia (IEO)
city: Milano
country: Italy
facility: MultiMedica Sesto san Giovanni
city: Milan
country: Italy
facility: IRCCS Fondazione istituto Nazionale dei Tumori
city: Modena
country: Italy
facility: Ospedale Civile Ramazzini di Carpi
city: Napoli
country: Italy
facility: Azienda Ospedaliera di Rilievo Nazionale Cardarelli
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
city: Novara
country: Italy
facility: Azienda Ospedaliero-Universitaria Maggiore della Carità
city: Padova
country: Italy
facility: IRCCS Istituto Oncologico Veneto IOV
city: Padova
country: Italy
facility: Ospedali di Cittadella e Camposampiero, ULSS 6 Euganea
city: Pagani
country: Italy
facility: Presidio Ospedaliero Andrea Tortora di Pagani
city: Palermo
country: Italy
facility: Azienda di rilievo nazionale e di Alta Specializzazione (ARNAS) Civico
city: Parma
country: Italy
facility: Azienda Ospedaliero-Universitaria Parma
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Pesaro
country: Italy
facility: Ospedali Riuniti Marche Nord
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria Pisana
city: Prato
country: Italy
facility: Nuovo Ospedale di Prato "Santo Stefano", Azienda USL Toscana Centro
city: Reggio Emilia
country: Italy
facility: Arcispedale S. Maria Nuova
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
city: Roma
country: Italy
facility: Azienda Ospedaliera San Giovanni Addolorata
city: Roma
country: Italy
facility: Azienda Ospedaliera San Giovanni Addolorata
city: Roma
country: Italy
facility: IRCCS Istituto Nazionale Tumori Regina Elena Roma
city: Roma
country: Italy
facility: Ospedale Santa Maria Goretti
city: Roma
country: Italy
facility: Policlinico Universitario Campus Bio-Medico
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Casa Sollievo della Sofferenza - San Giovanni Rotondo
city: Savona
country: Italy
facility: Ospedale San Paolo Savona
city: Terni
country: Italy
facility: Azienda Ospedaliera Santa Maria di Terni
city: Torino
country: Italy
facility: A.O Ordine Mauriziano
city: Torino
country: Italy
facility: Azienda Ospedaliero-Universitaria Città della Salute e della Scienza
city: Torino
country: Italy
facility: IRCCS Fondazione del Piemonte per l'Oncologia Candiolo
city: Trento
country: Italy
facility: Ospedale S. Chiara
city: Udine
country: Italy
facility: Azienda Sanitaria Universitaria Friuli Centrale - Ospedale "Santa Maria della Misericordia"
city: Verduno
country: Italy
facility: Ospedale Michele e Pietro Ferrero, ASL CN2
city: Vicenza
country: Italy
facility: AULSS 8 Berica
Study officials:
References: