Translational Cancer Observational Protocol

Recruiting

• Conditions: Upper Urinary Tract Urothelial Carcinoma
• Interventions: Procedure: Nephroureterectomy

• Registration Number: NCT06169436
• Lead Sponsor: IRCCS San Raffaele

Brief Summary

Observational study on relapse occurrence and on the quality of life in patients who underwent nephroureterectomy surgery

Detailed Description

Monocentric prospective and retrospective observational study on the quality of life and on the pathological status in patients who underwent nephroureterectomy surgery. Oncological, psychological, sexual and quality of life-related data will be collected within a specifically created database that will allow us an easy and secure data extraction for the statistical analysis required by the clinical trial in terms of oncological relapse, clinical progression and improve the assistance and therapeutic strategy for each patient. Retrospective data for patients who underwent surgery between 1987 and today will be available in the form of clinical report stored in the hospital archives.

Study Timeline

• Study Start: 2014-07-17
• Study First Submitted: 2023-11-23
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-05
• Last Update Submitted: 2023-12-05
• Study First Posted: 2023-12-13
• Last Update Posted: 2023-12-13
• Primary Completion: 2064-07-17
• Study Completion: 2064-07-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1250

Inclusion Criteria

• 18 years or older
• Upper tract urothelial cancer diagnosis
• Indication to cancer removal through nephroureterectomy surgery
• Ability to read and sign the informed consent

Exclusion Criteria

• Age < 18 years
• Absence of upper tract urothelial cancer
• Inability to read and sign the informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental	Nephroureterectomy	Patients with upper urinary tract urothelial cancer who underwent nephroureterectomy surgery

Primary Outcome Measures

Name	Time	Method
Clinical progression data collection	50 years	Collection intended for the purpose of implementing diagnostic and therepautic strategies for the management of the disease in both the patient enrolled in the study and for future cases. Data will be collected in a dedicated internal database by means of medical records obtained during the patients' stay in the hospital and during follow up visits. The data collected includes anamnesis, data regarding surgery, laboratory exam and imaging exams.

Trial Locations

Locations (1)

IRCCS Ospedale San Raffaele; 🇮🇹 Milan, MI, Italy