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)

Cepheid

Status: Completed

Conditions: Non-muscle-invasive Bladder Cancer

Treatments: Diagnostic Test: Xpert Bladder Cancer Monitor

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT03664258

ANTICIPATE X

Details and patient eligibility

About

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).

Full description

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

Enrollment: 852 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).