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Registry for patients with advanced urothelial carcinoma in Italy

Prospective and Multicenter Italian Registry of Locally Advanced-Metastatic Urothelial Carcinoma (Saturno Study)

Observational Federation of Italian Cooperative Oncology Groups · NCT06235268

This study is collecting information from adults with advanced bladder cancer in Italy who are getting treatment or palliative care to see how they are doing over two years.

Quick facts

Study typeObservational
Enrollment1000 (estimated)
Ages18 Years and up
SexAll
SponsorFederation of Italian Cooperative Oncology Groups Academic / other
Drugs / interventionschemotherapy
Locations52 sites (Ancona and 51 other locations)
Trial IDNCT06235268 on ClinicalTrials.gov

What this trial studies

This multicenter, prospective registry aims to collect data on adult patients with locally advanced or metastatic urothelial carcinoma who are receiving systemic treatment or undergoing palliative care. Patients will be monitored through regular medical visits and clinical-radiological evaluations as per standard clinical practice, without any additional procedures. The study will last for 24 months, including 12 months for patient enrollment and another 12 months for follow-up. The participating centers are strategically selected to represent various geographical areas in Italy.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 years old with a diagnosis of locally advanced or metastatic urothelial carcinoma who have not received prior chemotherapy for advanced disease.

Not a fit: Patients with previous chemotherapy for metastatic urothelial carcinoma or those with operable disease will not benefit from this study.

Why it matters

Potential benefit: If successful, this registry could enhance understanding of treatment outcomes and improve care strategies for patients with advanced urothelial carcinoma.

How similar studies have performed: While similar registries have been conducted, this specific approach focusing on advanced urothelial carcinoma in Italy is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Ancona and 51 other locations

+2 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Carcinoma, Urothelial
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.