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

Last updated: January 30, 2024
Sponsor: Federation of Italian Cooperative Oncology Groups
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carcinoma

Treatment

Active systemic or non-systemic treatment (palliative or observation procedure)

Clinical Study ID

NCT06235268
SATURNO
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Cytological and/or histological diagnosis of urothelial carcinoma or at least with oneurothelial 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 activesystemic treatments (iter palliative or observation) with certain diagnosis ofmetastatic disease
  • Patients with lymph node extension of the disease who are not candidates toneoadjuvant treatment
  • Any ECOG PS and therapeutic management is permitted.
  • Previous surgeries and antineoplastic treatments are permitted as long as not carriedout for metastatic disease (adjuvant and/or neoadjuvant)

Exclusion

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

Total Participants: 1000
Treatment Group(s): 1
Primary Treatment: Active systemic or non-systemic treatment (palliative or observation procedure)
Phase:
Study Start date:
November 23, 2023
Estimated Completion Date:
November 30, 2025

Study 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.

Connect with a study center

  • Azienda Ospedaliera Universitaria delle Marche

    Ancona,
    Italy

    Site Not Available

  • Ospedale Cardinal Massaia

    Asti,
    Italy

    Site Not Available

  • Centro Regionale Oncologico di Aviano

    Aviano,
    Italy

    Site Not Available

  • IRCCS Istituto Tumori Giovanni Paolo II

    Bari,
    Italy

    Site Not Available

  • Policlinico Universitario di Bari

    Bari,
    Italy

    Site Not Available

  • Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo,
    Italy

    Site Not Available

  • Spedali Civili

    Brescia,
    Italy

    Site Not Available

  • Azienda Ospedaliera per l'Emergenza Cannizzaro

    Catania,
    Italy

    Site Not Available

  • ASST Cremona

    Cremona,
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Carreggi

    Firenze,
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria, Policlinico Riuniti

    Foggia,
    Italy

    Site Not Available

  • Istituto Oncolgico Romagnolo di Meldola

    Forlì,
    Italy

    Site Not Available

  • IRCCS Ospedale Policlinico San Martino

    Genova,
    Italy

    Site Not Available

  • Ospedale Villa Scassi ASL 3 Genova

    Genova,
    Italy

    Site Not Available

  • Casa della Salute, Aprilia

    Latina,
    Italy

    Site Not Available

  • Ospedale Vito Fazzi

    Lecce,
    Italy

    Site Not Available

  • ASST OVEST Milanese - Ospedale di Legnano

    Legnano,
    Italy

    Site Not Available

  • IRCCS Fondazione istituto Nazionale dei Tumori

    Milan,
    Italy

    Active - Recruiting

  • Humanitas Research Hospital Rozzano

    Milano,
    Italy

    Site Not Available

  • Istituto Europeo di Oncologia (IEO)

    Milano,
    Italy

    Site Not Available

  • MultiMedica Sesto san Giovanni

    Milano,
    Italy

    Site Not Available

  • Ospedale Civile Ramazzini di Carpi

    Modena,
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Federico II

    Napoli,
    Italy

    Site Not Available

  • Azienda Ospedaliera di Rilievo Nazionale Cardarelli

    Napoli,
    Italy

    Site Not Available

  • Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

    Napoli,
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria Maggiore della Carità

    Novara,
    Italy

    Site Not Available

  • IRCCS Istituto Oncologico Veneto IOV

    Padova,
    Italy

    Site Not Available

  • Ospedali di Cittadella e Camposampiero, ULSS 6 Euganea

    Padova,
    Italy

    Site Not Available

  • Presidio Ospedaliero Andrea Tortora di Pagani

    Pagani,
    Italy

    Site Not Available

  • Azienda di rilievo nazionale e di Alta Specializzazione (ARNAS) Civico

    Palermo,
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria Parma

    Parma,
    Italy

    Site Not Available

  • Fondazione IRCCS Policlinico San Matteo

    Pavia,
    Italy

    Site Not Available

  • Ospedali Riuniti Marche Nord

    Pesaro,
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Pisana

    Pisa,
    Italy

    Site Not Available

  • Nuovo Ospedale di Prato "Santo Stefano", Azienda USL Toscana Centro

    Prato,
    Italy

    Site Not Available

  • Arcispedale S. Maria Nuova

    Reggio Emilia,
    Italy

    Site Not Available

  • Azienda Ospedaliera San Camillo Forlanini

    Roma,
    Italy

    Site Not Available

  • Azienda Ospedaliera San Giovanni Addolorata

    Roma,
    Italy

    Site Not Available

  • IRCCS Istituto Nazionale Tumori Regina Elena Roma

    Roma,
    Italy

    Site Not Available

  • Ospedale Santa Maria Goretti

    Roma,
    Italy

    Site Not Available

  • Policlinico Universitario Campus Bio-Medico

    Roma,
    Italy

    Site Not Available

  • IRCCS Casa Sollievo della Sofferenza - San Giovanni Rotondo

    San Giovanni Rotondo,
    Italy

    Site Not Available

  • Ospedale San Paolo Savona

    Savona,
    Italy

    Site Not Available

  • Azienda Ospedaliera Santa Maria di Terni

    Terni,
    Italy

    Site Not Available

  • A.O Ordine Mauriziano

    Torino,
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria Città della Salute e della Scienza

    Torino,
    Italy

    Site Not Available

  • IRCCS Fondazione del Piemonte per l'Oncologia Candiolo

    Torino,
    Italy

    Site Not Available

  • Ospedale S. Chiara

    Trento,
    Italy

    Site Not Available

  • Azienda Sanitaria Universitaria Friuli Centrale - Ospedale "Santa Maria della Misericordia"

    Udine,
    Italy

    Site Not Available

  • Ospedale Michele e Pietro Ferrero, ASL CN2

    Verduno,
    Italy

    Site Not Available

  • AULSS 8 Berica

    Vicenza,
    Italy

    Site Not Available

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