Carcinoma, UrothelialNCT06235268
Prospective and Multicenter Italian Registry of Locally Advanced-Metastatic Urothelial Carcinoma
An observational study of Carcinoma, Urothelial, run by Federation of Italian Cooperative Oncology Groups at 52 sites in Italy.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Urothelial
- What is being tested?
- Active systemic or non-systemic treatment (palliative or observation procedure)
- How many people
- 1,000 participants
- Where
- 52 sitesItaly
- Study dates
- 23 Nov 2023to Nov 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The registry will include all patients with metastatic urothelial carcinoma or with lymph node involvement defined as unsuitable for surgery.
Who may be able to join
- 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
Show all 10Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
52 sites in 1 country.
Marco Stellato contact
52 sites in 1 country
Italy52 sites, 51 recruiting
- Not yet recruiting
Azienda Ospedaliera Universitaria delle Marche
Ancona
Rossana Berardi, rossana.berardi@ospedali.riuniti.marche.it
- Not yet recruiting
Ospedale Cardinal Massaia
Asti
Marcello Tucci, mtucci@asl.at.it
- Not yet recruiting
Centro Regionale Oncologico di Aviano
Aviano
Lucia Fratino, lfratino@cro.it
- Not yet recruiting
IRCCS Istituto Tumori Giovanni Paolo II
Bari
Emanuele Naglieri, emanuele.naglieri@gmail.com
- Not yet recruiting
Policlinico Universitario di Bari
Bari
Mimma Rizzo, rizzo.mimma@gmail.com
- Not yet recruiting
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo
Laura Milesi, lmilesi@asst-pg23.it
- Not yet recruiting
Spedali Civili
Brescia
Alberto Dalla Volta, alberto.dallavolta@gmail.com
- Not yet recruiting
Azienda Ospedaliera per l'Emergenza Cannizzaro
Catania
Giuseppa Scandurra, giusy.scandurra@gmail.com
- Not yet recruiting
ASST Cremona
Cremona
Bruno Perrucci, bruno.perrucci@asst-cremona.it
- Not yet recruiting
Azienda Ospedaliera Universitaria Carreggi
Florence
Giandomenico Roviello, giandomenico.roviello@unifi.it
- Not yet recruiting
Azienda Ospedaliero-Universitaria, Policlinico Riuniti
Foggia
Vincenza Conteduca, vincenza.conteduca@unifg.it
- Not yet recruiting
Istituto Oncolgico Romagnolo di Meldola
Forlì
Ugo De Giorgi, ugo.degiorgi@irst.emr.it
- Not yet recruiting
IRCCS Ospedale Policlinico San Martino
Genova
Giuseppe Fornarini, Giuseppe.fornarini@hsanmartino.it
- Not yet recruiting
Ospedale Villa Scassi ASL 3 Genova
Genova
Alessia Cavo, alessia.cavo@asl3.liguria.it
- Not yet recruiting
Casa della Salute, Aprilia
Latina
Gianpaolo Spinelli, gianpaolo.spinelli@uniroma1.it
- Not yet recruiting
Ospedale Vito Fazzi
Lecce
Silvana Leo, silvileo59@gmail.com/lecce.oncologia@gmail.com
- Not yet recruiting
ASST OVEST Milanese - Ospedale di Legnano
Legnano
Elena Farè, elena.fare@asst-ovestmi.it
- Recruiting
IRCCS Fondazione istituto Nazionale dei Tumori
Milan
Giuseppe Procopio, giuseppe.procopio@istitutotumori.mi.it
- Not yet recruiting
Humanitas Research Hospital Rozzano
Milan
Paolo Andrea Zucali, paolo.zucali@hunimed.eu
- Not yet recruiting
Istituto Europeo di Oncologia (IEO)
Milan
Franco Nolè, franco.nole@ieo.it
- Not yet recruiting
MultiMedica Sesto san Giovanni
Milan
Riccardo Ricotta
- Not yet recruiting
Ospedale Civile Ramazzini di Carpi
Modena
Claudia Mucciarini, c.mucciarini@ausl.mo.it
- Not yet recruiting
Azienda Ospedaliera di Rilievo Nazionale Cardarelli
Naples
Sarah Scagliarini, SARAH.SCAGLIARINI@aocardarelli.it
- Not yet recruiting
Azienda Ospedaliera Universitaria Federico II
Naples
Luigi Formisano, luigi.formisano1@unina.it
- Active, not recruiting
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
Naples
- Not yet recruiting
Azienda Ospedaliero-Universitaria Maggiore della Carità
Novara
Carlo Cattrini, Carlo.cattrini@maggioreosp.novara.it
- Not yet recruiting
IRCCS Istituto Oncologico Veneto IOV
Padova
Marco Maruzzo, marco.maruzzo@iov.veneto.it
- Not yet recruiting
Ospedali di Cittadella e Camposampiero, ULSS 6 Euganea
Padova
Mariella Sorarù, mariella.soraru@aulss6.veneto.it
- Not yet recruiting
Presidio Ospedaliero Andrea Tortora di Pagani
Pagani
Giuseppe Di Lorenzo, g.dilorenzo@aslsalerno.it
- Not yet recruiting
Azienda di rilievo nazionale e di Alta Specializzazione (ARNAS) Civico
Palermo
Carlo Messina, carlo.messina@arnascivico.it
- Not yet recruiting
Azienda Ospedaliero-Universitaria Parma
Parma
Sebastiano Buti, sbuti@ao.pr.it
- Not yet recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia
Silvia Chiellino, S.Chiellino@smatteo.pv.it
- Not yet recruiting
Ospedali Riuniti Marche Nord
Pesaro
Rita Chiari, rita.chiari@ospedalimarchenord.it
- Not yet recruiting
Azienda Ospedaliera Universitaria Pisana
Pisa
Luca Galli, lugal71@yahoo.it
- Not yet recruiting
Nuovo Ospedale di Prato "Santo Stefano", Azienda USL Toscana Centro
Prato
Federico Paolieri, federico.paolieri@uslcentro.toscana.it
- Not yet recruiting
Arcispedale S. Maria Nuova
Reggio Emilia
Cristina Masini, cristina.masini@ausl.re.it
- Not yet recruiting
Azienda Ospedaliera San Camillo Forlanini
Roma
Linda Cerbone, cerbone.linda@gmail.com
- Not yet recruiting
Azienda Ospedaliera San Giovanni Addolorata
Roma
Federica Federica, frecine@hsangiovanni.roma.it
- Not yet recruiting
Azienda Ospedaliera San Giovanni Addolorata
Roma
Daniele Santinii, daniele.santini@uniroma1.it
- Not yet recruiting
IRCCS Istituto Nazionale Tumori Regina Elena Roma
Roma
Maria Bassanelli, maria.bassanelli@ifo.it
- Not yet recruiting
Ospedale Santa Maria Goretti
Roma
Nello Salesi
- Not yet recruiting
Policlinico Universitario Campus Bio-Medico
Roma
Luciano Stumbo, l.stumbo@policlinicocampus.it
- Not yet recruiting
IRCCS Casa Sollievo della Sofferenza - San Giovanni Rotondo
San Giovanni Rotondo
Brigida Anna Maiorano, b.maiorano@operapadrepio.it
- Not yet recruiting
Ospedale San Paolo Savona
Savona
Sara Rebuzzi, saraelena89@hotmail.it
- Not yet recruiting
Azienda Ospedaliera Santa Maria di Terni
Terni
Sergio Bracarda
- Not yet recruiting
A.O Ordine Mauriziano
Torino
Francesca Vignani, francesca.vignani@gmail.com
- Not yet recruiting
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza
Torino
Roberto Filippi, rfilippi@cittadellasalute.to.it
- Not yet recruiting
IRCCS Fondazione del Piemonte per l'Oncologia Candiolo
Torino
Alessandra Mosca
- Not yet recruiting
Ospedale S. Chiara
Trento
Antonello Veccia, antonello.veccia@apss.tn.it
- Not yet recruiting
Azienda Sanitaria Universitaria Friuli Centrale - Ospedale "Santa Maria della Misericordia"
Udine
Paola Ermacora, paola.ermacora@asufc.sanita.fvg.it
- Not yet recruiting
Ospedale Michele e Pietro Ferrero, ASL CN2
Verduno
Veronica Prati, vprati@aslcn2.it
- Not yet recruiting
AULSS 8 Berica
Vicenza
Rocco De Vivo, rocco.devivo@aulss8.veneto.it
About this study
Official title: 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
Read the 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.
- Conditions
- Carcinoma, Urothelial
- Being tested
- Active systemic or non-systemic treatment (palliative or observation procedure)
- Medical subject headings
- Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active systemic or non-systemic treatment (palliative or observation procedure)Other
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Survival from Diagnosis to time of death
Measured: 2 years
Progression free survival
the time from assignment to treatment to disease progression or death from any cause
Measured: up to 2 years
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].
Measured: up to 2 years
Treatment reality in Italy
description of treatments selected for patients per line of therapy over the course of the project
Measured: over 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start23 Nov 2023
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, UrothelialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Federation of Italian Cooperative Oncology Groups
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06235268
- Sponsor's protocol ID
- SATURNO
- Status last verified
- Jan 2024
- First submitted
- 22 Jan 2024
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective and Multicenter Italian Registry of Locally Advanced-Metastatic Urothelial Carcinoma (Saturno Study)
- ClinicalTrials.gov ID
- NCT06235268
- Acronym / sponsor ID
- SATURNO
- Conditions
- Carcinoma, Urothelial
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Federation of Italian Cooperative Oncology GroupsUniversity, hospital or other
- Study start
- 23 Nov 2023 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The registry will include all patients with metastatic urothelial carcinoma or with lymph node involvement defined as unsuitable for surgery.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | – |
Primary outcome
Overall survival
Time frame: 2 years
Survival from Diagnosis to time of death
Progression free survival
Time frame: up to 2 years
the time from assignment to treatment to disease progression or death from any cause
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].
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Stellato contact
52 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Urothelial, run by Federation of Italian Cooperative Oncology Groups at 52 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Procopio (0223903808, giuseppe.procopio@istitutotumori.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.