Ignite Creation Date:
2024-05-06 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05248282
Status:
UNKNOWN
Last Update Posted:
2022-02-21
First Post:
2022-02-10
Brief Title:
Clinical Validation of the Prognostic Value of the PrTS on Prostate Cancer Patients
Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Organization:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study Overview
Official Title:
A Single-Center Retrospective Blinded Validation Study to Investigate the Prognostic Value of the Prostatype Test System PrTS in Prostate Cancer Patients in China
Status:
UNKNOWN
Status Verified Date:
2022-02
Last Known Status:
RECRUITING
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:
Prostate Cancer is the most common type of cancer among men in many countries However current clinical tools have limited prediction accuracy to choose the optimal treatment for the individual patient as prostate cancer risk assessment is a critical aspect of treatment decision-making A substantial proportion of patients are undergoing over-treatment such as radical treatment which is often associated with negative physical and psychological side effects dramatically affecting quality of life in a negative way Moreover the patients that are under-treated will face higher cancer mortality risks which brings more concerns for patients and doctors Prostatype composes a one-step 4-plex quantitative reverse transcription polymerase chain reaction kit a database based on authenic patients information and a score system P-score intended to measure gene expression levels of three biomarkers IGFBP3 F3 and VGLL3 Genetic values combined with clinical parameters in the CPMA and P-score are aiming to estimate the aggressiveness of prostate tumor for a newly diagnosed prostate cancer patient This is a single-center retrospective blinded validation study aim to investigate the prognostic performance of the Prostatype test system
Detailed Description:
None
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