Clinical trial · Observational
Prospective and Multicenter Italian Registry of Locally Advanced-Metastatic Urothelial Carcinoma
Prospective and Multicenter Italian Registry of Locally Advanced-Metastatic Urothelial Carcinoma (Saturno Study)
NCT06235268CI-TRIAL-00073492unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Urothelial | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active systemic or non-systemic treatment (palliative or observation procedure) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Overall survival
- timeFrame
- 2 years
- description
- Survival from Diagnosis to time of death
- measure
- Progression free survival
- timeFrame
- up to 2 years
- description
- the time from assignment to treatment to disease progression or death from any cause
- measure
- Toxicities
- timeFrame
- up to 2 years
- description
- 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 \[5.0\].
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.