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Kidney Cancer Observational Protocol

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06147349
Enrollment
2500
Registered
2023-11-27
Start date
2010-01-27
Completion date
2028-02-04
Last updated
2023-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Cancer

Keywords

Renal cancer, Radical Nephrectomy, Partial Nephrectomy, Relapse, Renal cancer diagnosis, Renal cancer treatment

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.

Interventions

PROCEDURERadical or partial nephrectomy

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

Sponsors

IRCCS San Raffaele
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Clinical parameter collection10 yearsCollection 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.

Countries

Italy

Contacts

Primary ContactFrancesco Montorsi, MD.
montorsi.francesco@hsr.it02 2643 7286
Backup ContactFrancesco Fiorio, MSC
fiorio.francesco@hsr.it02 2643 6268

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026