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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06147349
Other study ID # 2007 - Rene
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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