Ignite Creation Date:
2024-05-06 @ 2:28 AM
Last Modification Date:
2024-10-26 @ 11:19 AM
Study NCT ID:
NCT02053805
Status:
UNKNOWN
Last Update Posted:
2017-10-17
First Post:
2014-01-30
Brief Title:
Prostate Cancer Screening Among Men With High Risk Genetic Predisposition
Sponsor:
Rabin Medical Center
Organization:
Rabin Medical Center
Study Overview
Official Title:
Personalized Prostate Cancer Screening Among Men With High Risk Genetic Predisposition- a Prospective Cohort Study
Status:
UNKNOWN
Status Verified Date:
2017-10
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:
This will be a prospective diagnostic trial of screening for prostate cancer among men with genetic predisposition
Detailed Description:
This will be a prospective diagnostic trial of screening for prostate cancer among men with genetic predisposition The target population is males 40-70 year old carrying a BRCA1 andor BRCA2 germ line mutation They will be identified via our Genetic counseling unit All men after signing an informed consent will undergo the following tests PSA free to total PSA MRI of prostate and prostate biopsy The primary endpoint will be to estimate the prevalence stage and grade of prostate cancer in this population Additionally the study aims to estimate the impact of these germ line mutations on benign prostatic hyperplasia Furthermore this study aims to create a bio-bank of tissue urine and serum of this unique cohort for future investigations Finally this study will identify an inception cohort for future interventional studies of primary and secondary prevention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None