Non-Invasive Bladder Urothelial CarcinomaXpert BladderNCT04647981
Diagnostic Performance Evaluation Study of the Xpert® Bladder Cancer Monitor Test.
An observational study of Non-Invasive Bladder Urothelial Carcinoma and Non-Invasive Bladder Papillary Urothelial Carcinoma, Low Grade, run by Clinique Beau Soleil at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Invasive Bladder Urothelial Carcinoma, Non-Invasive Bladder Papillary Urothelial Carcinoma, Low Grade, Non-Invasive Bladder Papillary Urothelial Carcinoma, High Grade
- What is being tested?
- Xpert® Bladder Cancer Monitor Test
- How many people
- 320 participants
- Where
- 1 siteFrance
- Study dates
- 22 May 2019to 2 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A person with antecedents of non-invasive bladder tumors and who has had previous transurethral resection of bladder tumor.
Who may be able to join
- Participant has a social security scheme.
- Participant has signed a form of no objection to the use of the data.
- Participant has had a transurethral resection of bladder tumor revealing non-invasive-muscle bladder tumor prior to inclusion within a maximum of 5 years from the date of diagnosis to the absence of recurrence since then.
- Participant is seen for a follow-up cystoscopy on the day of the visit.
- Non-Inclusion Criteria:
- Vulnerable persons (Article L 1121-6 of the Public Health Code).
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- Adults subject to legal protection or unable to express their consent (Article 1121-8 of the Public Health Code).
- Persons with a bladder tumor other than a non-invasive bladder tumor (i.e., invasive bladder cancer).
- A person who has undergone bladder tumor resection or therapy with Calmette-Guerin bacilli or with Mitomycin C less than 6 weeks (42 days) prior to inclusion.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Performance Evaluation Study of the Xpert® Bladder Cancer Monitor Test in the Surveillance of Patients With Non-Invasive Bladder Urothelial Carcinoma.
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.
Read more
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.
Read the detailed 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.
- Conditions
- Non-Invasive Bladder Urothelial Carcinoma, Non-Invasive Bladder Papillary Urothelial Carcinoma, Low Grade, Non-Invasive Bladder Papillary Urothelial Carcinoma, High Grade
- Being tested
- Xpert® Bladder Cancer Monitor Test
- Keywords
- Bladder, Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xpert® Bladder Cancer Monitor TestOther
The urine sample is analyzed with the Xpert® Bladder Cancer Monitor test.
| Study group | Role | What they receive |
|---|---|---|
| Xpert® Bladder Test | A urine sample is collected before cystoscopy. Receives: Other: Xpert® Bladder Cancer Monitor Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start22 May 2019
- Primary completion15 Dec 2020
- Study completion2 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Invasive Bladder Urothelial CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Beau Soleil
- Sponsor type
- University, hospital or other
- Collaborators
- Cepheid, Team Languedoc Mutualité / Nouvelles technologies
- Responsible party
- Sponsor
- Investigators
- Mohamed Trabelssi, M.D., Principal investigator, Clinique Beau Soleil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04647981
- Sponsor's protocol ID
- 2018-A03392-53
- Acronym
- Xpert Bladder
- Status last verified
- Feb 2021
- First submitted
- 23 Nov 2020
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance Evaluation Study of the Xpert® Bladder Cancer Monitor Test in the Surveillance of Patients With Non-Invasive Bladder Urothelial Carcinoma.
- ClinicalTrials.gov ID
- NCT04647981
- Acronym / sponsor ID
- Xpert Bladder / 2018-A03392-53
- Conditions
- Non-Invasive Bladder Urothelial Carcinoma, Non-Invasive Bladder Papillary Urothelial Carcinoma, Low Grade, Non-Invasive Bladder Papillary Urothelial Carcinoma, High Grade
- Keywords
- Bladder, Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Clinique Beau SoleilUniversity, hospital or other
- Collaborators
- Cepheid, Team Languedoc Mutualité / Nouvelles technologies
- Study start
- 22 May 2019 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 2 Jan 2021 (actual)
- First posted
- 1 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Xpert® Bladder Test | – | Other: Xpert® Bladder Cancer Monitor TestA urine sample is collected before cystoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A person with antecedents of non-invasive bladder tumors and who has had previous transurethral resection of bladder tumor.
Key inclusion criteria (9 listed)
- Participant has a social security scheme.
- Participant has signed a form of no objection to the use of the data.
- Participant has had a transurethral resection of bladder tumor revealing non-invasive-muscle bladder tumor prior to inclusion within a maximum of 5 years from the date of diagnosis to the absence of recurrence since then.
- Participant is seen for a follow-up cystoscopy on the day of the visit.
- Vulnerable persons (Article L 1121-6 of the Public Health Code).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xpert® Bladder Cancer Monitor TestThe urine sample is analyzed with the Xpert® Bladder Cancer Monitor test. | Other | Xpert® Bladder Test |
Primary outcome
Compare sensitivities of the Xpert® Bladder Cancer Monitor Test and the urinary cytology test.
Time frame: 12 months
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.
1 secondary outcome
Evaluate the diagnostic accuracy of the Xpert® Bladder Cancer Monitor test.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Qualitative monitoring for recurrence in patients previously diagnosed with bladder cancer in 90 minutes.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Trabelssi, M.D. principal investigator
Clinique Beau Soleil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Invasive Bladder Urothelial Carcinoma and Non-Invasive Bladder Papillary Urothelial Carcinoma, Low Grade, run by Clinique Beau Soleil at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare sensitivities of the Xpert® Bladder Cancer Monitor Test and the urinary cytology test. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.