Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:59 PM
Study NCT ID:
NCT05810467
Status:
RECRUITING
Last Update Posted:
2024-10-15
First Post:
2023-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Active Surveillance Study
Sponsor:
Institute of Cancer Research, United Kingdom
Organization:
Study Overview
Official Title:
Active Surveillance Study for Prostate Cancer Management for Men At Higher Genetic Risk Compared with Men At No Known Higher Genetic Risk.
Status:
RECRUITING
Status Verified Date:
2024-10
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:
AS
Brief Summary:
The Active Surveillance study is a prospective study developed to look at the association of biomarkers with PrCa presentation and progression among men on Active Surveillance and stratify it by their genetic risk. This study will also investigate the incidence and progression by differing genetic risks.
Detailed Description:
This prospective study will look at the association of biomarkers with PrCa presentation and progression among men on Active Surveillance and stratify it by their genetic risk. This study will also investigate the incidence and progression by differing genetic risks. The study will review the serial PSA and imaging data for men in AS comparing and contrasting the men of known higher genetic risk for PrCa with those without. Additionally, the study aims to collect samples to investigate the profile of plasma, serum, urine, stool and saliva biomarkers in men at a higher genetic risk of PrCa, who have been diagnosed with low risk PrCa and are undergoing Active Surveillance. It will also review the association of specific genetic profiles and biomarkers (biological samples - plasma, serum, urine, stool and saliva). These markers will be compared and contrasted with samples from men with no known increased genetic risk for PrCa.
The study aims to recruit a total of 200 men with low grade PrCa, aged ≥18 into two cohorts (i.e. men on AS who are known to be at higher genetic risk and those on AS with no known increased genetic risk of PrCa. Patients will be identified through the urology clinics at the Royal Marsden Hospital. These will be men who are already registered at the Royal Marsden Hospital and undergoing active surveillance (as determined by the MDT).
The study aims to recruit a total of 200 men with low grade PrCa, aged ≥18 into two cohorts (i.e. men on AS who are known to be at higher genetic risk and those on AS with no known increased genetic risk of PrCa. Patients will be identified through the urology clinics at the Royal Marsden Hospital. These will be men who are already registered at the Royal Marsden Hospital and undergoing active surveillance (as determined by the MDT).
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: