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| Name | Class |
|---|---|
| Cepheid | INDUSTRY |
| Team Languedoc Mutualité / Nouvelles technologies | UNKNOWN |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xpert® Bladder Test | A urine sample is collected before cystoscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xpert® Bladder Cancer Monitor Test | Other | The urine sample is analyzed with the Xpert® Bladder Cancer Monitor test. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare sensitivities of the Xpert® Bladder Cancer Monitor Test and the urinary cytology test. | The two tests, the Xpert® Bladder Cancer Monitor and the urinary cytology, made during the follow-up of patients with non-invasive-muscle bladder tumor are compared to the gold standard, which is the reference examination: the couple cystoscopy/histology. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the diagnostic accuracy of the Xpert® Bladder Cancer Monitor test. | Evaluate the diagnostic accuracy of the Xpert® Bladder Cancer Monitor test for the detection of bladder tumor recurrence (stage, grade). | 12 months |
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Inclusion Criteria:
Non-Inclusion Criteria:
Exclusion Criteria:
- Participant no longer wishing to participate in the study, or in the course of the study with a refusal to use the data until exit from the study.
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A person with antecedents of non-invasive bladder tumors and who has had previous transurethral resection of bladder tumor.
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed Trabelssi, M.D. | Clinique Beau Soleil | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Beau Soleil | Montpellier | Hérault | 34070 | France |
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| Label | URL |
|---|---|
| Qualitative monitoring for recurrence in patients previously diagnosed with bladder cancer in 90 minutes. | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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