Prospective and Multicenter Italian Registry of Locally Advanced-Metastatic Urothelial Carcinoma
1 other identifier
observational
1,000
1 country
52
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2023
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 23, 2023
CompletedFirst Submitted
Initial submission to the registry
January 22, 2024
CompletedFirst Posted
Study publicly available on registry
January 31, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2025
CompletedJanuary 31, 2024
January 1, 2024
1.9 years
January 22, 2024
January 30, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
Overall survival
Survival from Diagnosis to time of death
2 years
Progression free survival
the time from assignment to treatment to disease progression or death from any cause
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 \[5.0\].
up to 2 years
Treatment reality in Italy
description of treatments selected for patients per line of therapy over the course of the project
over 2 years
Interventions
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.
Eligibility Criteria
The registry will include all patients with metastatic urothelial carcinoma or with lymph node involvement defined as unsuitable for surgery.
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (52)
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
Florence, 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
Milan, Italy
Istituto Europeo di Oncologia (IEO)
Milan, Italy
MultiMedica Sesto san Giovanni
Milan, 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
Padua, Italy
Ospedali di Cittadella e Camposampiero, ULSS 6 Euganea
Padua, 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, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2024
First Posted
January 31, 2024
Study Start
November 23, 2023
Primary Completion
November 1, 2025
Study Completion
November 1, 2025
Last Updated
January 31, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share