Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06147349
Status:
RECRUITING
Last Update Posted:
2023-11-27
First Post:
2023-10-10
Brief Title:
Kidney Cancer Observational Protocol
Sponsor:
IRCCS San Raffaele
Organization:
IRCCS San Raffaele
Study Overview
Official Title:
2007 - Rene Observational Study on the Occurrence of Possible Relapses and on the Quality of Life in Patients Who Underwent Radical NefrectomyTumorectomy Surgery
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None