Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06397755
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2023-10-13
Brief Title:
Observational Study of Patients Who Underwent Diagnostic Investigation Prostate Biopsy andor Radical Prostatectomy Surgery
Sponsor:
IRCCS San Raffaele
Organization:
IRCCS San Raffaele
Study Overview
Official Title:
Observational Study of Patients Who Underwent Diagnostic Investigation Prostate Biopsy andor Radical Prostatectomy Surgery
Status:
RECRUITING
Status Verified Date:
2024-04
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 and retrospective study on quality of life and disease status of patients who underwent prostate biopsy andor radical prostatectomy
Detailed Description:
A database was created with the intention of collecting data related to patients who underwent prostate biopsy andor radical prostatectomy
Only anamnesis and biopsy procedure data are collected for patients underwent prostate biopsy
Anamnesis surgery histological report and hospitalization data are collected for patients who underwent radical prostatectomy
Each patient will be followed for 50 years from the date of radical prostatectomy surgery
Each patient will receive a questionnaire before radical prostatectomy A follow up questionnaire will be collected after surgery relating to quality of life The data for each patient will then be transferred to the database itself The data collected will be handled following the most strict GCPs and privacy norms
Only anamnesis and biopsy procedure data are collected for patients underwent prostate biopsy
Anamnesis surgery histological report and hospitalization data are collected for patients who underwent radical prostatectomy
Each patient will be followed for 50 years from the date of radical prostatectomy surgery
Each patient will receive a questionnaire before radical prostatectomy A follow up questionnaire will be collected after surgery relating to quality of life The data for each patient will then be transferred to the database itself The data collected will be handled following the most strict 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