Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04647981 |
| Other study ID # |
2018-A03392-53 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 22, 2019 |
| Est. completion date |
January 2, 2021 |
Study information
| Verified date |
February 2021 |
| Source |
Clinique Beau Soleil |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
This study consists of a urine sample. During the participant's medical consultation with
his/her urologist, for the monitoring of his/her non-invasive bladder tumor(s), a cystoscopy
is performed. Before the examination, the participant gives a urine sample, which will be
analyzed by the Xpert®Bladder 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 (e.g. 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.
