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)

Cepheid852 enrolled

Overview

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).

Patient recruitment and follow-up are closed. The study is in analysis phase.

Study Type

OBSERVATIONAL

Enrollment

852

Conditions

Non-muscle-invasive Bladder Cancer

Interventions

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (13)

University Clinic for Urology and Andrology

Salzburg, Austria

Medical University of Vienna

Vienna, Austria

Teaching Hospital Motol

Prague, Czechia

CHU Toulouse / Institut Universitaire du Cancer Toulouse Oncopole

Toulouse, France

Klinikum Braunschweig

Braunschweig, Germany

University of Regensburg

Regensburg, Germany

Humanitas University - Gradenigo Hospital of Turin

Turin, Italy

Academic Medical Center

Amsterdam, Netherlands

Fundacio Puigvert

Barcelona, Spain

Instituto Valenciano de Oncologia

Valencia, Spain

...and 3 more locations

Outcomes

Primary Outcomes

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).

Time frame: 12 months from patient enrollment in the study.

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.

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.

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.

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.

Time frame: 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).

Time frame: 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.

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.

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

Time frame: 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.

Time frame: At patient enrollment.