Kidney Cancer Observational Protocol

Sponsor

IRCCS San Raffaele (Other)

Overall Status

Recruiting

CT.gov ID

NCT06147349

Collaborator

(none)

2,500

Enrollment

Location

216.2

Anticipated Duration (Months)

11.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Cancer	Procedure: Radical or partial nephrectomy

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

2500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

2007 - Rene: Observational Study on the Occurrence of Possible Relapses and on the Quality of Life in Patients Who Underwent Radical Nefrectomy/Tumorectomy Surgery

Actual Study Start Date :

Jan 27, 2010

Anticipated Primary Completion Date :

Feb 4, 2028

Anticipated Study Completion Date :

Feb 4, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental Patients with kidney cancer who underwent radical or partial kidney removal surgery	Procedure: Radical or partial nephrectomy Removal of neoplastic mass either by full kidney excision or by targeted cancer removal

Arm

Intervention/Treatment

Experimental

Patients with kidney cancer who underwent radical or partial kidney removal surgery

Procedure: Radical or partial nephrectomy

Removal of neoplastic mass either by full kidney excision or by targeted cancer removal

Outcome Measures

Primary Outcome Measures

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.