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NCT06235268

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

Last Updated: 2024-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-23

Study Completion Date

2025-11-30

Brief Summary

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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

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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.

Conditions

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Carcinoma, Urothelial

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Active systemic or non-systemic treatment (palliative or observation procedure)

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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Locations

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