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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 23, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 31, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 31, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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