Non-muscle-invasive Bladder CancerANTICIPATE XNCT03664258
A Multi-National Study In Bladder Cancer Patients to Detect Recurrences After TURB (Trans-urethral Resection of the Bladder) Earlier With the Xpert Bladder Cancer Monitor Assay (ANTICIPATE X)
An observational study of Non-muscle-invasive Bladder Cancer, run by Cepheid at 13 sites in 9 countries.
Trial summary
Bladder cancer is the 5th most common cancer in Europe, with more than 151,000 new cases diagnosed in 2012 (4% of the total). Bladder cancer has the highest recurrence rate of any malignancy, often as high as 70% within 5 years of successful treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-muscle-invasive Bladder Cancer
- What is being tested?
- Xpert Bladder Cancer Monitor
- How many people
- 852 participants
- Where
- 13 sitesin 9 countries
- Study dates
- 6 Jun 2018to 31 Jan 2022
- 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
- Adult, Older adult
Study population: Patients diagnosed with low or intermediate risk NMIBC and included in a monitoring program are considered for the study. Patients are recruited within the medical consultation of the Urology departments of the study sites (hospitals, clinics) and registered following a chronological order.
Who may be able to join
- Patient undergoing a follow-up cystoscopy at the time of enrolment for low or intermediate risk NMIBC patients in the follow-up phase (according to the 2017 EAU guidelines),
- Patient must accept to be followed for 1 year after enrolment cystoscopy,
- Patient who can provide urine samples naturally (e.g. no catheterization),
- 18 years or older at the time of enrolment,
- Signed informed consent.
Who cannot join
- Patient with history of NMIBC stratified at the time of enrolment as high risk according to 2017 EAU Guidelines,
- Patient with history of Muscle-Invasive Bladder Cancer (MIBC),
- Patient having undergone a TURB less than 3 months before enrolment,
- Patient having received Mitomycin C (MMC) or Bacillus Calmette-Guerin (BCG) intravesical instillations less than 3 months before enrolment (a single MMC post-operative instillation is acceptable for inclusion).
Trial locations and contacts
13 sites in 9 countries.
13 sites in 9 countries
Austria2 sites
University Clinic for Urology and Andrology
Salzburg
Medical University of Vienna
Vienna, A-1090
Germany2 sites
Klinikum Braunschweig
Braunschweig
University of Regensburg
Regensburg, 93053
Spain2 sites
Fundacio Puigvert
Barcelona, 08025
Instituto Valenciano de Oncologia
Valencia
United Kingdom2 sites
Royal Surrey County Hospital
Guildford, GU2 7XX
Sunderland City Hospital
Sunderland
France1 site
CHU Toulouse / Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, 31100
About this study
Official title: Evaluation of the Xpert® Bladder Cancer Monitor Assay Compared to Cystoscopy for the Follow-up of Patients With History of Low or Intermediate Risk Non-muscle-invasive Bladder Cancer (NMIBC): an Observational Prospective International Multicenter Study
Bladder cancer is the 5th most common cancer in Europe, with more than 151,000 new cases diagnosed in 2012 (4% of the total). Bladder cancer has the highest recurrence rate of any malignancy, often as high as 70% within 5 years of successful treatment. This high recurrence rate requires diligent and accurate monitoring as a means for early diagnosis and treatment. Considering the burden associated to repeated invasive cystoscopies, there is a need for robust but accurate tests for surveillance. In that prospect, urinary molecular tests have been developed although none were deemed adequate in the European clinical guidelines to replace cystoscopies. The Xpert Bladder Cancer Monitor Assay is a qualitative in vitro diagnostic test designed to monitor for the recurrence of bladder cancer in patients previously diagnosed with this cancer. The test provides a fast and accurate result, is non-invasive and easy to perform. The aim of this study is to assess the non-inferiority of the Xpert Bladder Cancer Monitor assay in detecting recurrences in comparison to cystoscopy in the follow-up of patients with low or intermediate risk non-muscle-invasive bladder cancer (NMIBC).
Read the detailed description
Patient recruitment and follow-up are closed. The study is in analysis phase.
- Conditions
- Non-muscle-invasive Bladder Cancer
- Being tested
- Xpert Bladder Cancer Monitor
- 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 Cancer MonitorDiagnostic test
The Xpert Bladder Cancer Monitor Assay is a qualitative in vitro diagnostic test designed to monitor for the recurrence of bladder cancer in patients previously diagnosed with bladder cancer. It should be used in conjunction with other clinical measures to assess disease recurrence. The test provides a fast and accurate result, is non-invasive and easy to perform.The test utilizes a voided urine specimen and measures the level of five target mRNAs (ABL1, CRH, IGF2, UPK1B, ANXA10) by means of real-time, reverse transcription-polymerase chain reaction (RT-PCR).
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the comparison of the number of recurrences detected between the standard of care (cystoscopy) and a urine biomarker assay
The primary outcome measure is the ratio of patients presenting recurrence, comparing the number of patients with positive cystoscopies over the duration of 12 months to the number of patients with positive Xpert Bladder Cancer Monitor Assay at D0 (at enrollment).
Measured: 12 months from patient enrollment in the study.
Secondary outcomes (6)
Comparison of the number of patients with negative Xpert Bladder Cancer Monitor assay results and the number of patients with negative cystoscopy results at D0 who are not presenting with recurrent bladder cancer within 12 months of enrolment cystoscopy.
The number of patients with negative Xpert Bladder Cancer Monitor assay results will be compared to the number of patients with negative cystoscopy results at D0 who are not presenting with recurrent bladder cancer within 12 months of enrolment cystoscopy. The absence of cancer is defined as absence of suggestion of cancer on cystoscopy performed over 12 months or positive cystoscopy at 12 months not confirmed by TURB.
Measured: 12 months from patient enrollment in the study.
Comparison of the number of positive and negative tests of Xpert Bladder Cancer Monitor and cystoscopy results at the time of each NMIBC follow-up assessment.
The number of positive and negative tests of Xpert Bladder Cancer Monitor will be compared to the cystoscopy results at the time of each NMIBC follow-up assessment.
Measured: At each patient follow-up up to 12 months of study.
EuroQol Five Dimensions Questionnaire (EQ-5D-5L questionnaire) at Day 0
Measure of the quality of life of patients with the EQ-5D-5L questionnaire at Day 0 for 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression).
Measured: At patient enrollment
Patient numeric scale for cystoscopy discomfort
Evaluation of patient's cystoscopy discomfort with a patient numeric scale to complete by the patient after each. The patient self-rates on a 0 (no discomfort) to 10 (maximum discomfort) numeric scale.
Measured: At each patient follow-up up to 12 months of study.
Assessment of medical care resources consumption related to bladder cancer at 1 month after each cystoscopy.
Assessment of medical care resources consumption related to bladder cancer follow-up with the use of a patient questionnaire completed 1 month after each cystoscopy:
- Number of general practitioner or urologist visits performed during 1 month after the cystoscopy.
- Number of hospitalization/ duration of hospitalization during 1 month after the cystoscopy
- Nature of additional medical examination performed during 1 month after the cystoscopy
- Nature of additional treatments received during 1 month after the cystoscopy
- Number of sick leave/ duration of sick leave during 1 month after the cystoscopy
Measured: 1 month after each cystoscopy through study completion.
EuroQol health visual analogue scale at Day 0.
Measure of the patient self-rated health on a vertical visual analogue scale numbered from 0 (best health) to 100 (worst health) at Day 0.
Measured: At patient enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start6 Jun 2018
- Primary completion31 Dec 2021
- Study completion31 Jan 2022
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 852 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cepheid
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Axonal-Biostatem, Stève Consultants
- Responsible party
- Sponsor
- Investigators
- Bernard Malavaud, M.D., Principal investigator, CHU Toulouse / Institut Universitaire du Cancer Toulouse Oncopole
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03664258
- Sponsor's protocol ID
- ANTICIPATE X
- Acronym
- ANTICIPATE X
- Status last verified
- Aug 2021
- First submitted
- 25 Jul 2018
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Xpert® Bladder Cancer Monitor Assay Compared to Cystoscopy for the Follow-up of Patients With History of Low or Intermediate Risk Non-muscle-invasive Bladder Cancer (NMIBC): an Observational Prospective International Multicenter Study
- ClinicalTrials.gov ID
- NCT03664258
- Acronym / sponsor ID
- ANTICIPATE X / ANTICIPATE X
- Conditions
- Non-muscle-invasive Bladder Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 852 participants (actual)
- Lead sponsor
- CepheidIndustry (pharma, biotech, devices)
- Collaborators
- Axonal-Biostatem, Stève Consultants
- Study start
- 6 Jun 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 10 Sep 2018 (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.
Bladder cancer is the 5th most common cancer in Europe, with more than 151,000 new cases diagnosed in 2012 (4% of the total). Bladder cancer has the highest recurrence rate of any malignancy, often as high as 70% within 5 years of successful treatment. This high recurrence rate requires diligent and accurate monitoring as a means for early diagnosis and treatment. Considering the burden associated to repeated invasive cystoscopies, there is a need for robust but accurate tests for surveillance. In that prospect, urinary molecular tests have been developed although none were deemed adequate in the European clinical guidelines to replace cystoscopies. The Xpert Bladder Cancer Monitor Assay is a qualitative in vitro diagnostic test designed to monitor for the recurrence of bladder cancer in patients previously diagnosed with this cancer. The test provides a fast and accurate result, is non-invasive and easy to perform. The aim of this study is to assess the non-inferiority of the Xpert Bladder Cancer Monitor assay in detecting recurrences in comparison to cystoscopy in the follow-up of patients with low or intermediate risk non-muscle-invasive bladder cancer (NMIBC).
Detailed description
Patient recruitment and follow-up are closed. The study is in analysis phase.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with low or intermediate risk NMIBC and included in a monitoring program are considered for the study. Patients are recruited within the medical consultation of the Urology departments of the study sites (hospitals, clinics) and registered following a chronological order.
Key inclusion criteria (5 listed)
- Patient undergoing a follow-up cystoscopy at the time of enrolment for low or intermediate risk NMIBC patients in the follow-up phase (according to the 2017 EAU guidelines),
- Patient must accept to be followed for 1 year after enrolment cystoscopy,
- Patient who can provide urine samples naturally (e.g. no catheterization),
- 18 years or older at the time of enrolment,
- Signed informed consent.
Key exclusion criteria (4 listed)
- Patient with history of NMIBC stratified at the time of enrolment as high risk according to 2017 EAU Guidelines,
- Patient with history of Muscle-Invasive Bladder Cancer (MIBC),
- Patient having undergone a TURB less than 3 months before enrolment,
- Patient having received Mitomycin C (MMC) or Bacillus Calmette-Guerin (BCG) intravesical instillations less than 3 months before enrolment (a single MMC post-operative instillation is acceptable for inclusion).
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 MonitorThe Xpert Bladder Cancer Monitor Assay is a qualitative in vitro diagnostic test designed to monitor for the recurrence of bladder cancer in patients previously diagnosed with bladder cancer. It should be used in conjunction with other clinical measures to assess disease recurrence. The test provides a fast and accurate result, is non-invasive and easy to perform.The test utilizes a voided urine specimen and measures the level of five target mRNAs (ABL1, CRH, IGF2, UPK1B, ANXA10) by means of real-time, reverse transcription-polymerase chain reaction (RT-PCR). | Diagnostic test | – |
Primary outcome
The primary endpoint is the comparison of the number of recurrences detected between the standard of care (cystoscopy) and a urine biomarker assay
Time frame: 12 months from patient enrollment in the study.
The primary outcome measure is the ratio of patients presenting recurrence, comparing the number of patients with positive cystoscopies over the duration of 12 months to the number of patients with positive Xpert Bladder Cancer Monitor Assay at D0 (at enrollment).
6 secondary outcomes
Comparison of the number of patients with negative Xpert Bladder Cancer Monitor assay results and the number of patients with negative cystoscopy results at D0 who are not presenting with recurrent bladder cancer within 12 months of enrolment cystoscopy.
Time frame: 12 months from patient enrollment in the study.
Comparison of the number of positive and negative tests of Xpert Bladder Cancer Monitor and cystoscopy results at the time of each NMIBC follow-up assessment.
Time frame: At each patient follow-up up to 12 months of study.
EuroQol Five Dimensions Questionnaire (EQ-5D-5L questionnaire) at Day 0
Time frame: At patient enrollment
Patient numeric scale for cystoscopy discomfort
Time frame: At each patient follow-up up to 12 months of study.
Assessment of medical care resources consumption related to bladder cancer at 1 month after each cystoscopy.
Time frame: 1 month after each cystoscopy through study completion.
EuroQol health visual analogue scale at Day 0.
Time frame: At patient enrollment.
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 13 Feb 2023.
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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.
Bernard Malavaud, M.D. principal investigator
CHU Toulouse / Institut Universitaire du Cancer Toulouse Oncopole
13 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-muscle-invasive Bladder Cancer, run by Cepheid at 13 sites in 9 countries.
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 5 inclusion and 4 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 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Austria, Germany, Spain, United Kingdom, Czechia and 4 more countries. 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?
The primary endpoint is the comparison of the number of recurrences detected between the standard of care (cystoscopy) and a urine biomarker assay (time frame: 12 months from patient enrollment in the study.). 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 13 Feb 2023.