Ignite Creation Date:
2024-05-06 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05889195
Status:
RECRUITING
Last Update Posted:
2024-01-19
First Post:
2023-05-22
Brief Title:
Detection and Risk Stratification in Veterans Presenting With Microscopic Hematuria
Sponsor:
Pacific Edge Limited
Organization:
Pacific Edge Limited
Study Overview
Official Title:
Validation of Cxbladder Detect-Plus for the Detection of Urothelial Carcinoma in Subjects With Microscopic Hematuria microDRIVE
Status:
RECRUITING
Status Verified Date:
2024-07
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:
microDRIVE
Brief Summary:
It is of current debate whether the use of invasive referring to a process that requires insertion into the body standard of care procedures such as a cystoscopy which is a procedure to look inside the bladder using a thin camera called a cystoscope is appropriate for use in patients with microscopic hematuria or blood in urine invisible to the naked eye This is because the risk of disease bladder cancer - urothelial carcinoma is relatively low in this population group approximately 3 Invasive procedures such as a cystoscopy comes with anxiety and pain in addition to other potential side effects This has resulted in low admittance in urology clinics for cystoscopy with hematuria blood in urine patients Therefore there is a need for a more simple non-invasive test that can accurately detect the presence or absence of disease urothelial carcinoma in patients with microscopic hematuria There is a potential role Cxbladder a non-invasive urine based test can fill this role
Detailed Description:
This is a multicenter observational study prospectively enrolling up to 1000 subjects with microscopic hematuria from Veterans Affairs Medical Centers This study will be conducted with subjects with a previous history of microscopic hematuria three or more red blood cells per high powered field in one urinalysis undergoing clinical assessment including cystoscopy Consented eligible subjects will undergo all standard of care tests as clinically indicated In addition one additional urine sample using remote at-home sampling will be collected to validate the performance characteristics for the Cxbladder Detect-plus test The urine sample collected from each subject will be a voided urine sample at one time point prior to the scheduled cystoscopy
The primary aim of this study is to validate the use of Cxbladder Detect-plus as an effective diagnostic tool to
1 Enable patients with microscopic hematuria who have a low probability of having disease urothelial carcinoma to be ruled out from further investigation This will avoid expensive invasive work-up without compromising detection of disease
2 Allow physicians to identify subjects at high risk of disease urothelial carcinoma
3 Replace less sensitive urine-based tests such as urine cytology or other urine genomic tests currently available
4 Adjudicate atypical cytology or equivocal cystoscopy results
Cxbladder results will not be reported to the subjects or the physicians Each subject will be required to fill in the date of sample collection in the test-request form and Cxbladder tubes The site will fill in case-report forms in a professional manner in accordance with good clinical practice GCP
The primary aim of this study is to validate the use of Cxbladder Detect-plus as an effective diagnostic tool to
1 Enable patients with microscopic hematuria who have a low probability of having disease urothelial carcinoma to be ruled out from further investigation This will avoid expensive invasive work-up without compromising detection of disease
2 Allow physicians to identify subjects at high risk of disease urothelial carcinoma
3 Replace less sensitive urine-based tests such as urine cytology or other urine genomic tests currently available
4 Adjudicate atypical cytology or equivocal cystoscopy results
Cxbladder results will not be reported to the subjects or the physicians Each subject will be required to fill in the date of sample collection in the test-request form and Cxbladder tubes The site will fill in case-report forms in a professional manner in accordance with good clinical practice GCP
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