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NCT Number: 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)

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).

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Key information

Conditions

Non-muscle-invasive Bladder Cancer Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-Muscle Invasive Bladder Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Clinic for Urology and Andrology, Salzburg, Austria

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About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Xpert Bladder Cancer Monitor

Diagnostic Test

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).

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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

  6. 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.

Sponsors and collaborators

Lead sponsor

Cepheid

Industry

Collaborators

  • Axonal-Biostatem
  • Stève Consultants

Registry information

Official study 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

Acronym: ANTICIPATE X

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Sep 10, 2018
Registry last updated
Feb 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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