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

January 30, 2024 updated by: Federation of Italian Cooperative Oncology Groups

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Ancona, Italy
      • Asti, Italy
        • Not yet recruiting
        • Ospedale Cardinal Massaia
        • Contact:
      • Aviano, Italy
        • Not yet recruiting
        • Centro Regionale Oncologico di Aviano
        • Contact:
      • Bari, Italy
      • Bari, Italy
      • Bergamo, Italy
        • Not yet recruiting
        • Azienda Ospedaliera Papa Giovanni XXIII
        • Contact:
      • Brescia, Italy
      • Catania, Italy
        • Not yet recruiting
        • Azienda Ospedaliera per l'emergenza Cannizzaro
        • Contact:
      • Cremona, Italy
      • Firenze, Italy
      • Foggia, Italy
        • Not yet recruiting
        • Azienda Ospedaliero-Universitaria, Policlinico Riuniti
        • Contact:
      • Forlì, Italy
      • Genova, Italy
      • Genova, Italy
      • Latina, Italy
      • Lecce, Italy
      • Legnano, Italy
      • Milan, Italy
      • Milano, Italy
        • Not yet recruiting
        • Humanitas Research Hospital Rozzano
        • Contact:
      • Milano, Italy
        • Not yet recruiting
        • Istituto Europeo di Oncologia (IEO)
        • Contact:
      • Milano, Italy
        • Not yet recruiting
        • MultiMedica Sesto san Giovanni
        • Contact:
          • Riccardo Ricotta
      • Modena, Italy
      • Napoli, Italy
      • Napoli, Italy
      • Napoli, Italy
        • Active, not recruiting
        • Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
      • Novara, Italy
      • Padova, Italy
      • Padova, Italy
      • Pagani, Italy
        • Not yet recruiting
        • Presidio Ospedaliero Andrea Tortora di Pagani
        • Contact:
      • Palermo, Italy
        • Not yet recruiting
        • Azienda di rilievo nazionale e di Alta Specializzazione (ARNAS) Civico
        • Contact:
      • Parma, Italy
        • Not yet recruiting
        • Azienda Ospedaliero-Universitaria Parma
        • Contact:
      • Pavia, Italy
      • Pesaro, Italy
      • Pisa, Italy
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria Pisana
        • Contact:
      • Prato, Italy
      • Reggio Emilia, Italy
      • Roma, Italy
      • Roma, Italy
        • Not yet recruiting
        • Azienda Ospedaliera San Camillo Forlanini
        • Contact:
      • Roma, Italy
      • Roma, Italy
        • Not yet recruiting
        • IRCCS Istituto Nazionale Tumori Regina Elena Roma
        • Contact:
      • Roma, Italy
        • Not yet recruiting
        • Ospedale Santa Maria Goretti
        • Contact:
          • Nello Salesi
      • San Giovanni Rotondo, Italy
        • Not yet recruiting
        • IRCCS Casa Sollievo della Sofferenza - San Giovanni Rotondo
        • Contact:
      • Savona, Italy
      • Terni, Italy
        • Not yet recruiting
        • Azienda Ospedaliera Santa Maria di Terni
        • Contact:
          • Sergio Bracarda
      • Torino, Italy
      • Torino, Italy
      • Torino, Italy
        • Not yet recruiting
        • IRCCS Fondazione del Piemonte per l'Oncologia Candiolo
        • Contact:
          • Alessandra Mosca
      • Trento, Italy
      • Udine, Italy
        • Not yet recruiting
        • Azienda Sanitaria Universitaria Friuli Centrale - Ospedale "Santa Maria della Misericordia"
        • Contact:
      • Verduno, Italy
        • Not yet recruiting
        • Ospedale Michele e Pietro Ferrero, ASL CN2
        • Contact:
      • Vicenza, Italy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federation of Italian Cooperative Oncology Groups

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 23, 2023

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

January 22, 2024

First Submitted That Met QC Criteria

January 30, 2024

First Posted (Estimated)

January 31, 2024

Study Record Updates

Last Update Posted (Estimated)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SATURNO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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