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) (ANTICIPATE X)

February 9, 2023 updated by: Cepheid

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

852

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria
        • University Clinic for Urology and Andrology
      • Vienna, Austria, A-1090
        • Medical University of Vienna
  • Czechia
      • Praha, Czechia
        • Teaching Hospital Motol
  • France
      • Toulouse, France, 31100
        • CHU Toulouse / Institut Universitaire du Cancer Toulouse Oncopole
  • Germany
      • Braunschweig, Germany
        • Klinikum Braunschweig
      • Regensburg, Germany, 93053
        • University of Regensburg
  • Italy
      • Turin, Italy
        • Humanitas University - Gradenigo Hospital of Turin
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Academic Medical Center
  • Spain
      • Barcelona, Spain, 08025
        • Fundacio Puigvert
      • Valencia, Spain
        • Instituto Valenciano de Oncologia
  • Sweden
      • Göteborg, Sweden, 41345
        • Sahlgrenska University Hospital
  • United Kingdom
      • Guildford, United Kingdom, GU2 7XX
        • Royal Surrey County Hospital
      • Sunderland, United Kingdom
        • Sunderland City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 months from patient enrollment in the study.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
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
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).
At patient enrollment
Patient numeric scale for cystoscopy discomfort
Time Frame: At each patient follow-up up to 12 months of study.
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.
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.

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
1 month after each cystoscopy through study completion.
EuroQol health visual analogue scale at Day 0.
Time Frame: At patient enrollment.
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.
At patient enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cepheid

Collaborators

Axonal-Biostatem
Stève Consultants

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 6, 2018

Primary Completion (ACTUAL)

December 31, 2021

Study Completion (ACTUAL)

January 31, 2022

Study Registration Dates

First Submitted

July 25, 2018

First Submitted That Met QC Criteria

September 6, 2018

First Posted (ACTUAL)

September 10, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 13, 2023

Last Update Submitted That Met QC Criteria

February 9, 2023

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANTICIPATE X

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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