Clinical trial NCT03664258: 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)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-muscle-invasive Bladder Cancer
Lead sponsor: Cepheid
Sponsor class: INDUSTRY
Collaborators: name: Axonal-Biostatem
name: Stève Consultants
First posted: 2018-09-10
Enrollment: 852
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: The primary endpoint is the comparison of the number of recurrences detected between the standard of care (cystoscopy) and a urine biomarker assay
timeFrame: 12 months from patient enrollment in the study.
Secondary outcomes:
measure: 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.
timeFrame: 12 months from patient enrollment in the study.
measure: 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.
timeFrame: At each patient follow-up up to 12 months of study.
measure: EuroQol Five Dimensions Questionnaire (EQ-5D-5L questionnaire) at Day 0
timeFrame: At patient enrollment
measure: Patient numeric scale for cystoscopy discomfort
timeFrame: At each patient follow-up up to 12 months of study.
measure: Assessment of medical care resources consumption related to bladder cancer at 1 month after each cystoscopy.
timeFrame: 1 month after each cystoscopy through study completion.
measure: EuroQol health visual analogue scale at Day 0.
timeFrame: At patient enrollment.
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: University Clinic for Urology and Andrology
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Praha
country: Czechia
facility: Teaching Hospital Motol
city: Toulouse
country: France
facility: CHU Toulouse / Institut Universitaire du Cancer Toulouse Oncopole
city: Braunschweig
country: Germany
facility: Klinikum Braunschweig
city: Regensburg
country: Germany
facility: University of Regensburg
city: Turin
country: Italy
facility: Humanitas University - Gradenigo Hospital of Turin
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
city: Barcelona
country: Spain
facility: Fundacio Puigvert
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncologia
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital
city: Sunderland
country: United Kingdom
facility: Sunderland City Hospital
Study officials:
affiliation: CHU Toulouse / Institut Universitaire du Cancer Toulouse Oncopole
name: Bernard Malavaud, M.D.
role: PRINCIPAL_INVESTIGATOR
References: