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Trial Title:
Kidney Cancer Observational Protocol
NCT ID:
NCT06147349
Condition:
Renal Cancer
Conditions: Official terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Conditions: Keywords:
Renal cancer
Radical Nephrectomy
Partial Nephrectomy
Relapse
Renal cancer diagnosis
Renal cancer treatment
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Radical or partial nephrectomy
Description:
Removal of neoplastic mass either by full kidney excision or by targeted cancer removal
Arm group label:
Experimental
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.
Criteria for eligibility:
Study pop:
Patients with kidney cancer who underwent radical or partial nephrectomy
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
IRCCS Ospedale San Raffaele
Address:
City:
Milan
Zip:
20132
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Francesco Fiorio, MSC
Phone:
02 2643 6268
Email:
fiorio.francesco@hsr.it
Start date:
January 27, 2010
Completion date:
February 4, 2028
Lead sponsor:
Agency:
IRCCS San Raffaele
Agency class:
Other
Source:
IRCCS San Raffaele
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06147349
