Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06310759
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-02-05
Brief Title:
Prospective Validation Study of High Volume Urine DNA Testing in Individuals with Suspicion of Urothelial Cancer
Sponsor:
Tampere University Hospital
Organization:
Tampere University Hospital
Study Overview
Official Title:
Observational Prospective Multicenter Validation Study Investigating the Possibility of Replacing Cystoscopies with High Volume Urine DNA Testing in Individuals with Suspicion of Urothelial Cancer UROSCOUT-1
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:
UROSCOUT-1
Brief Summary:
Urothelial cancers of the bladder and upper urinary tract account for over 200000 deaths and 600000 diagnoses annually worldwide The most common presenting symptom is hematuria blood in urine triggering a cascade of tests including an invasive examination of the bladder using a flexible scope cystoscopy Millions of cystoscopies are performed every year worldwide for patients presenting with hematuria but only 10 result in a cancer diagnosis The UROSCOUT-1 trial is a prospective multicenter observational study that explores the potential of urine tumor DNA utDNA testing to replace a significant portion of cystoscopies in the diagnostic setting for hematuria or other reasons to rule out urothelial cancer The goal is to enhance patient quality of life reduce healthcare costs and address increased workloads in urology centers Sample collection will be conducted by mail and the samples will be analyzed in a blinded manner without knowledge of which patients are diagnosed with cancer Random subsampling will be applied to cancer-negative patients to achieve an approximate 11 ratio between cancer-positive and -negative patients
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