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

Recruiting

• Conditions: Carcinoma, Urothelial

• Registration Number: NCT06235268
• Lead Sponsor: Federation of Italian Cooperative Oncology Groups

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

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 Timeline

• Study Start: 2023-11-23
• Status Verified: 2024-01
• Study First Submitted: 2024-01-22
• Study First Submitted QC: 2024-01-30
• Last Update Submitted: 2024-01-30
• Study First Posted: 2024-01-31
• Last Update Posted: 2024-01-31
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	2 years	Survival from Diagnosis to time of death
Toxicities	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 \[5.0\].
Progression free survival	up to 2 years	the time from assignment to treatment to disease progression or death from any cause
Treatment reality in Italy	over 2 years	description of treatments selected for patients per line of therapy over the course of the project

Trial Locations

Locations (51)

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; 🇮🇹 Firenze, Italy

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