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)

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 852 (actual)
• Sponsor: Cepheid · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Non-muscle-invasive Bladder Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Xpert Bladder Cancer Monitor	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).

Timeline

• Start date: 2018-06-06
• Primary completion: 2021-12-31
• Completion: 2022-01-31
• First posted: 2018-09-10
• Last updated: 2023-02-13

Locations

13 sites across 9 countries: Austria, Czechia, France, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom