Kidney Cancer Observational Protocol

Recruiting

• Conditions: Renal Cancer
• Interventions: Procedure: Radical or partial nephrectomy

• Registration Number: NCT06147349
• Lead Sponsor: IRCCS San Raffaele

Brief Summary

The aim of this observational study is to gather pre and post surgery clinical data belonging to patients who underwent radical or partial nephrectomy and to evaluate the impact of the surgery on the quality of life of the patients, as well as possible relapses within a 10 year period.

Detailed Description

A databasa was created with the intention of collecting data related to patients who underwent radical or partial nefrectomy surgery in an electronic case report form.

Each patient will be followed for 10 years approximately starting from the date of surgery for a total of 2 yearly visits for the first 5 years which could then be diluted in 1 visit per year for the remaining 5 years. At each visit control exams forseen by the standard care for post surgery patients will be evalued and tha data will then be transferred into the database. Yearly, a follow up questionnaire will be sent to the patients' home in order to obtain the information relative to possible relapses. The data collected will be handled following the most strict GCPs and privacy norms. The main objectives of the study are the collection and interpretation of the scientific data with the scope of: obtaining health benefits for the patients involved and for future patients with the same type of cancer, improving the scientific knowledge on the pathology and implementing new strategies for diagnosis and therapy and evaluating the epidemiologic changes of renal neoplasia.

Study Timeline

• Study Start: 2010-01-27
• Study First Submitted: 2023-10-10
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-23
• Last Update Submitted: 2023-11-23
• Study First Posted: 2023-11-27
• Last Update Posted: 2023-11-27
• Primary Completion: 2028-02-04
• Study Completion: 2028-02-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

• 18 years or older
• Kidney cancer diagnosis
• Indication to cancer removal through surgery
• Ability to read and sign the informed consent

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental	Radical or partial nephrectomy	Patients with kidney cancer who underwent radical or partial kidney removal surgery

Primary Outcome Measures

Name	Time	Method
Clinical parameter collection	10 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.

Trial Locations

Locations (1)

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