Kidney Cancer Observational Protocol

Renal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06147349
• Other study ID #: 2007 - Rene
• Status: Recruiting
• Start date: January 27, 2010
• Est. completion date: February 4, 2028

Study information

• Verified date: November 2023
• Source: IRCCS San Raffaele
• Contact: Francesco Montorsi, MD.
• Phone: 02 2643 7286
• Email: montorsi.francesco[@]hsr.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: February 4, 2028
• Est. primary completion date: February 4, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Neoplasms
• Renal Cancer

Intervention

Procedure:
• Radical or partial nephrectomy
Removal of neoplastic mass either by full kidney excision or by targeted cancer removal

Locations

Country	Name	City	State
Italy	IRCCS Ospedale San Raffaele	Milan	MI

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical parameter collection	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.	10 years