Ignite Creation Date:
2024-05-06 @ 3:29 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04647981
Status:
COMPLETED
Last Update Posted:
2021-02-09
First Post:
2020-11-23
Brief Title:
Diagnostic Performance Evaluation Study of the Xpert Bladder Cancer Monitor Test
Sponsor:
Clinique Beau Soleil
Organization:
Clinique Beau Soleil
Study Overview
Official Title:
Diagnostic Performance Evaluation Study of the Xpert Bladder Cancer Monitor Test in the Surveillance of Patients With Non-Invasive Bladder Urothelial Carcinoma
Status:
COMPLETED
Status Verified Date:
2021-02
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:
Xpert Bladder
Brief Summary:
Non-muscle invasive bladder tumor is a condition that can recur with a risk of progression to an infiltrating tumor of the muscle Regular follow-up is therefore essential to detect any recurrence or progression of the disease as early as possible
Currently the monitoring of this type of tumor is done by cystoscopy examination that allows visualization of the bladder wall associated with urinary cytology analysis of urine to detect an abnormality These examinations have their limits they may not detect certain types of tumors or may be painful
To reduce the number of cystoscopies and replace urinary cytology several urinary markers have been developed in recent years This is the case of the Xpert Bladder Cancer Monitor test which is a non-invasive in vitro diagnostic urine test dedicated to the monitoring of patients with bladder cancer
The purpose of this study is to evaluate the diagnostic performance of the Xpert Bladder Cancer Monitor test for the detection of bladder tumor recurrence compared to reference tests
Currently the monitoring of this type of tumor is done by cystoscopy examination that allows visualization of the bladder wall associated with urinary cytology analysis of urine to detect an abnormality These examinations have their limits they may not detect certain types of tumors or may be painful
To reduce the number of cystoscopies and replace urinary cytology several urinary markers have been developed in recent years This is the case of the Xpert Bladder Cancer Monitor test which is a non-invasive in vitro diagnostic urine test dedicated to the monitoring of patients with bladder cancer
The purpose of this study is to evaluate the diagnostic performance of the Xpert Bladder Cancer Monitor test for the detection of bladder tumor recurrence compared to reference tests
Detailed Description:
This study consists of a urine sample During the participants medical consultation with hisher urologist for the monitoring of hisher non-invasive bladder tumors a cystoscopy is performed Before the examination the participant gives a urine sample which will be analyzed by the XpertBladder Cancer Monitor test
The main objective of this non-interventional monocentric study is to compare the sensitivity of the Xpert Bladder Cancer Monitor test performed on the GeneXpert system to the sensitivity of cytology
The reference test is a combination of cystoscopy and histology The algorithm is as follows if the cystoscopy is negative it will be considered that there is no recurrence if the cystoscopy is positive a biopsy of the abnormal area will be performed and histology will be requested If the histology is positive it will be considered that there is a recurrence otherwise it will be considered that there is no recurrence
The gold standard is therefore the couple cystoscopy - histology
A cystoscopy will be considered positive if to the naked eye the urologist sees a macroscopically suspicious lesion eg a budding lesion
If the cystoscopy is positive the urologist will take a sample of the suspect lesion and have it analyzed by the pathologist If the lesion analyzed has the same histology as the original lesion it will be considered a recurrence
The main objective of this non-interventional monocentric study is to compare the sensitivity of the Xpert Bladder Cancer Monitor test performed on the GeneXpert system to the sensitivity of cytology
The reference test is a combination of cystoscopy and histology The algorithm is as follows if the cystoscopy is negative it will be considered that there is no recurrence if the cystoscopy is positive a biopsy of the abnormal area will be performed and histology will be requested If the histology is positive it will be considered that there is a recurrence otherwise it will be considered that there is no recurrence
The gold standard is therefore the couple cystoscopy - histology
A cystoscopy will be considered positive if to the naked eye the urologist sees a macroscopically suspicious lesion eg a budding lesion
If the cystoscopy is positive the urologist will take a sample of the suspect lesion and have it analyzed by the pathologist If the lesion analyzed has the same histology as the original lesion it will be considered a recurrence
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