Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06154499
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-04
First Post:
2023-10-13
Brief Title:
Archive Prostate Observational Study of Patients Who Underwent Radical Prostatectomy Surgery
Sponsor:
IRCCS San Raffaele
Organization:
IRCCS San Raffaele
Study Overview
Official Title:
Archive Prostate Observational Study of Patients Who Underwent Radical Prostatectomy Surgery Long-term Evaluation of the Course of Prostate Cancer Associated With Quality of Life Post-surgery Treatments and Occurrence of Any Disease Recurrence
Status:
ACTIVE_NOT_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:
This is a single-center observational prospective study on quality of life and disease status of patients who underwent radical prostatectomy Data related to clinical conditions oncological psychological sexual and quality of life of these patients are collected in a database
Detailed Description:
A database was created with the intention of collecting data related to patients with diagnosis of prostate cancer who underwent radical prostatectomy
Anamnesis surgery histological report and hospitalization data are collected for patients who underwent radical prostatectomy
Each patient will be followed for 10 years from the date of radical prostatectomy surgery
Each patient will receive a questionnaire before radical prostatectomy in order to evaluate the quality of life urinary continence erectile function and psycho-physical wellbeing A follow up questionnaire will be collected after surgery in order to analyze the predictive factors of the disease clinical progression and to obtain health benefits for the patients involved and for future patients with the same tipe of cancer improving the scientific knowledge of the pathology and implementing new strategies for diagnosis and therapy and evaluating the epidemiologic changes of prostate cancer Tha data collected will be handles following the most strict Good Clinical Practice GCPs and privacy norms
Anamnesis surgery histological report and hospitalization data are collected for patients who underwent radical prostatectomy
Each patient will be followed for 10 years from the date of radical prostatectomy surgery
Each patient will receive a questionnaire before radical prostatectomy in order to evaluate the quality of life urinary continence erectile function and psycho-physical wellbeing A follow up questionnaire will be collected after surgery in order to analyze the predictive factors of the disease clinical progression and to obtain health benefits for the patients involved and for future patients with the same tipe of cancer improving the scientific knowledge of the pathology and implementing new strategies for diagnosis and therapy and evaluating the epidemiologic changes of prostate cancer Tha data collected will be handles following the most strict Good Clinical Practice GCPs and privacy norms
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