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

Carcinoma, Urothelial Clinical Trial

Official title:

Prospective and Multicenter Italian Registry of Locally Advanced-Metastatic Urothelial Carcinoma (Saturno Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06235268
• Other study ID #: SATURNO
• Status: Recruiting
• Start date: November 23, 2023
• Est. completion date: November 2025

Study information

• Verified date: January 2024
• Source: Federation of Italian Cooperative Oncology Groups
• Contact: Giuseppe Procopio
• Phone: 0223903808
• Email: giuseppe.procopio[@]istitutotumori.mi.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Transitional Cell
• Carcinoma, Urothelial

Intervention

Other:
• Active 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.

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Universitaria delle Marche	Ancona
Italy	Ospedale Cardinal Massaia	Asti
Italy	Centro Regionale Oncologico di Aviano	Aviano
Italy	IRCCS Istituto Tumori Giovanni Paolo II	Bari
Italy	Policlinico Universitario di Bari	Bari
Italy	Azienda Ospedaliera Papa Giovanni XXIII	Bergamo
Italy	Spedali Civili	Brescia
Italy	Azienda Ospedaliera per l'Emergenza Cannizzaro	Catania
Italy	ASST Cremona	Cremona
Italy	Azienda Ospedaliera Universitaria Carreggi	Firenze
Italy	Azienda Ospedaliero-Universitaria, Policlinico Riuniti	Foggia
Italy	Istituto Oncolgico Romagnolo di Meldola	Forlì
Italy	IRCCS Ospedale Policlinico San Martino	Genova
Italy	Ospedale Villa Scassi ASL 3 Genova	Genova
Italy	Casa della Salute, Aprilia	Latina
Italy	Ospedale Vito Fazzi	Lecce
Italy	ASST OVEST Milanese - Ospedale di Legnano	Legnano
Italy	IRCCS Fondazione istituto Nazionale dei Tumori	Milan
Italy	Humanitas Research Hospital Rozzano	Milano
Italy	Istituto Europeo di Oncologia (IEO)	Milano
Italy	MultiMedica Sesto san Giovanni	Milano
Italy	Ospedale Civile Ramazzini di Carpi	Modena
Italy	Azienda Ospedaliera di Rilievo Nazionale Cardarelli	Napoli
Italy	Azienda Ospedaliera Universitaria Federico II	Napoli
Italy	Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"	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	Azienda Ospedaliero-Universitaria Parma	Parma
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	Azienda Ospedaliera San Giovanni Addolorata	Roma
Italy	Azienda Ospedaliera San Giovanni Addolorata	Roma
Italy	IRCCS Istituto Nazionale Tumori Regina Elena Roma	Roma
Italy	Ospedale Santa Maria Goretti	Roma
Italy	Policlinico Universitario Campus Bio-Medico	Roma
Italy	IRCCS Casa Sollievo della Sofferenza - San Giovanni Rotondo	San Giovanni Rotondo
Italy	Ospedale San Paolo Savona	Savona
Italy	Azienda Ospedaliera Santa Maria di Terni	Terni
Italy	A.O Ordine Mauriziano	Torino
Italy	Azienda Ospedaliero-Universitaria Città della Salute e della Scienza	Torino
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	AULSS 8 Berica	Vicenza

Sponsors (1)

Lead Sponsor	Collaborator
Federation of Italian Cooperative Oncology Groups

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Survival from Diagnosis to time of death	2 years
Primary	Progression free survival	the time from assignment to treatment to disease progression or death from any cause	up to 2 years
Primary	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].	up to 2 years
Primary	Treatment reality in Italy	description of treatments selected for patients per line of therapy over the course of the project	over 2 years