Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2025-12-29 @ 8:24 PM
Study NCT ID:
NCT06235268
Status:
RECRUITING
Last Update Posted:
2024-01-31
First Post:
2024-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective and Multicenter Italian Registry of Locally Advanced-Metastatic Urothelial Carcinoma
Sponsor:
Federation of Italian Cooperative Oncology Groups
Organization:
Study Overview
Official Title:
Prospective and Multicenter Italian Registry of Locally Advanced-Metastatic Urothelial Carcinoma (Saturno Study)
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: