Non Muscle Invasive Bladder CancerCEPHEIDNCT02895620
Effect on Xpert® Bladder Test of Urines Inflammatory Milieu Induced by BCG Treatment of Patients With NMIBC
A study testing Xpert bladder Test in people with Non Muscle Invasive Bladder Cancer and Treatment by BCG, run by Institut Claudius Regaud at 1 site in France.
Trial summary
Intravesical BCG immunotherapy is used after transurethral resection (TUR) for the prevention of recurrence of NMIBC. BCG treatment is usually started a few weeks after TUR and is given once a week for 6 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Muscle Invasive Bladder Cancer, Treatment by BCG
- What is being tested?
- Xpert bladder Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2016to Aug 2017
- Phase
- Interventional
- 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
Who may be able to join
- Patients presenting with high-risk transitional cell carcinoma of the bladder, according to the EAU guidelines/EORTC risk stratification, who are offered adjuvant BCG instillations.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Institut claudius regaud IUCT ONCOPOLE
Toulouse, 31059
philippe ROCHAIX, MD, 531156407, rochaix.philippe@iuct-oncopole.fr
About this study
Official title: Evaluation of the Effect of a Complex Inflammatory Milieu Induced by BCG Treatment in Urines of Patients With Non-muscle-invasive Bladder Cancer on the Xpert® Bladder Cancer Assay
Intravesical BCG immunotherapy is used after transurethral resection (TUR) for the prevention of recurrence of NMIBC. BCG treatment is usually started a few weeks after TUR and is given once a week for 6 weeks. It stimulates immune responses that can destroy bladder cancer cells (acute and chronic induced inflammations) and as a consequence causes side effects. The investigators postulate that Xpert® test might be used to demonstrate the presence of residual (after TURB) or recurrent (during adjuvant treatment) disease at the time of intravesical treatment, which could be of very significant impact in the management of this complex situation.Urines of BCG treated patients are rich in immune system elements (cytokines, lymphocytes,…), this complex inflammatory milieu of urines may interfere with urinary biomarkers. This study will allow assessing the effect of the complex inflammatory milieu induced by BCG treatment in urines of patients with NMIBC on the Xpert® Bladder cancer assay.
Read the detailed description
- Qualification of Xpert® Testing: Three 50 mL fresh urine samples will be collected in sterile containers according to Cepheid instructions of use:
- the "baseline sample" before the first BCG instillation,
- the "study sample" taken during the initiation course of treatment instillations, preferably at the 4th or 5th instillation of BCG therapy,
- the "follow-up sample" at the time of the first follow-up cystoscopy, approximately 3 months after the last BCG instillation of the initiation course. Xpert® test results will be qualified as positive or negative, according to Cepheid instructions for use. Samples tested positive at baseline will not be included in the analysis and the patient's participation in the study will be discontinued. Samples obtained in patients with no recurrence at follow-up cystoscopy after the initiation course will be considered for analysis.
- Threshold of detection of theXpert® Bladder test:
- One urine sample of a patient tumor free (negative Xpert test) under BCG treatment will be spiked into 3 log dilutions of the 2 distinct tumor cell lines SW780 and BE(2)-C (100, 1000, and 10000 cells per ml).
- A mix of fresh and frozen cells from en bloc harvested tumors from distinct donors will be tested at the set concentration in BCG urines from distinct patients.
- Being tested
- Xpert bladder Test
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xpert bladder TestBiological
Xpert test positive or negative on urine samples of NMIBC patients treated by BCG
| Study group | Role | What they receive |
|---|---|---|
| NMIBC patients Xpert bladder test | Other | Xpert bladder test of urine of patients with NMIBC treated with BCG therapy Receives: Biological: Xpert bladder Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of negative Xpert tests results during the initiation course in patients with no recurrence at first follow-up cystoscopy
Measured: 12 months
Secondary outcomes (1)
rate of Xpert tests found positive in samples with predefined tumour cell concentrations ( limit of detection) in inflammatory milieu of urines induced by the BCG treatment in patients with bladder cancer
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 posted9 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Muscle Invasive Bladder CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Collaborators
- Cepheid
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02895620
- Sponsor's protocol ID
- 16HLURO01
- Acronym
- CEPHEID
- Status last verified
- Sep 2016
- First submitted
- 6 Sep 2016
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of a Complex Inflammatory Milieu Induced by BCG Treatment in Urines of Patients With Non-muscle-invasive Bladder Cancer on the Xpert® Bladder Cancer Assay
- ClinicalTrials.gov ID
- NCT02895620
- Acronym / sponsor ID
- CEPHEID / 16HLURO01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Collaborators
- Cepheid
- Study start
- Aug 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 9 Sep 2016 (estimated)
- 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.
Intravesical BCG immunotherapy is used after transurethral resection (TUR) for the prevention of recurrence of NMIBC. BCG treatment is usually started a few weeks after TUR and is given once a week for 6 weeks. It stimulates immune responses that can destroy bladder cancer cells (acute and chronic induced inflammations) and as a consequence causes side effects. The investigators postulate that Xpert® test might be used to demonstrate the presence of residual (after TURB) or recurrent (during adjuvant treatment) disease at the time of intravesical treatment, which could be of very significant impact in the management of this complex situation.Urines of BCG treated patients are rich in immune system elements (cytokines, lymphocytes,…), this complex inflammatory milieu of urines may interfere with urinary biomarkers. This study will allow assessing the effect of the complex inflammatory milieu induced by BCG treatment in urines of patients with NMIBC on the Xpert® Bladder cancer assay.
Detailed description
- Qualification of Xpert® Testing: Three 50 mL fresh urine samples will be collected in sterile containers according to Cepheid instructions of use:
- the "baseline sample" before the first BCG instillation,
- the "study sample" taken during the initiation course of treatment instillations, preferably at the 4th or 5th instillation of BCG therapy,
- the "follow-up sample" at the time of the first follow-up cystoscopy, approximately 3 months after the last BCG instillation of the initiation course. Xpert® test results will be qualified as positive or negative, according to Cepheid instructions for use. Samples tested positive at baseline will not be included in the analysis and the patient's participation in the study will be discontinued. Samples obtained in patients with no recurrence at follow-up cystoscopy after the initiation course will be considered for analysis.
- Threshold of detection of theXpert® Bladder test:
- One urine sample of a patient tumor free (negative Xpert test) under BCG treatment will be spiked into 3 log dilutions of the 2 distinct tumor cell lines SW780 and BE(2)-C (100, 1000, and 10000 cells per ml).
- A mix of fresh and frozen cells from en bloc harvested tumors from distinct donors will be tested at the set concentration in BCG urines from distinct patients.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NMIBC patients Xpert bladder test | Other | Biological: Xpert bladder TestXpert bladder test of urine of patients with NMIBC treated with BCG therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients presenting with high-risk transitional cell carcinoma of the bladder, according to the EAU guidelines/EORTC risk stratification, who are offered adjuvant BCG instillations.
Key exclusion criteria (1 listed)
- -
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 TestXpert test positive or negative on urine samples of NMIBC patients treated by BCG | Biological | NMIBC patients Xpert bladder test |
Primary outcome
Rate of negative Xpert tests results during the initiation course in patients with no recurrence at first follow-up cystoscopy
Time frame: 12 months
1 secondary outcome
rate of Xpert tests found positive in samples with predefined tumour cell concentrations ( limit of detection) in inflammatory milieu of urines induced by the BCG treatment in patients with bladder cancer
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2016.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xpert bladder Test in people with Non Muscle Invasive Bladder Cancer and Treatment by BCG, run by Institut Claudius Regaud 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 1 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: status not confirmed, as of the sponsor's last update on 9 Sep 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philipppe ROCHAIX, MD (531156407 ext. 33, rochaix.philippe@iuct-onocpole.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of negative Xpert tests results during the initiation course in patients with no recurrence at first follow-up cystoscopy (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 Sep 2016.