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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)

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ClinicalTrials.gov Identifier: NCT03664258
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
Axonal Biostatem CRO
Information provided by (Responsible Party):
Cepheid

Brief 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).

Condition or disease Intervention/treatment
Non-muscle-invasive Bladder Cancer Diagnostic Test: Xpert Bladder Cancer Monitor

Detailed Description:
Site selection is closed. Patient recruitment is ongoing.

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Study Type : Observational
Estimated Enrollment : 1100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Actual Study Start Date : June 6, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer


Intervention Details:
  • 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).


Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients diagnosed with low or intermediate risk NMIBC and included in a monitoring program will be considered for the study. Patients will be recruited within the medical consultation of the Urology departments of the study sites (hospitals, clinics) and registered following a chronological order.
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03664258


Contacts
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Contact: Laura Fabre, PharmD +33 563 825 392 laura.fabre@cepheid.com
Contact: Anne Postulka, M.D. +33 5 63 82 53 38 anne.postulka@cepheid.com

Locations
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Austria
Medical University of Vienna Recruiting
Vienna, Austria, A-1090
Contact: Kilian Gust, MD    +43 1 40400 26150    kilian.gust@meduniwien.ac.at   
Sub-Investigator: Kilian Gust, MD         
Principal Investigator: Shahrokh Shariat, Prof         
Czechia
Teaching Hospital Motol Recruiting
Praha, Czechia
Contact: Barbora Provaznikova    +420224434848    barbora.provaznikova@fnmotol.cz   
Principal Investigator: Antonin Brisuda, MD         
France
CHU Toulouse / Institut Universitaire du Cancer Toulouse Oncopole Recruiting
Toulouse, France, 31100
Contact: Bernard Malavaud, MD    +33 5 31 15 53 38    Malavaud.Bernard@iuct-oncopole.fr   
Sub-Investigator: Mathieu Roumiguié, MD         
Principal Investigator: Bernard Malavaud, MD         
Germany
University of Regensburg Recruiting
Regensburg, Germany, 93053
Contact: Johannes Breyer, MD    +49 941 782 3534    johannes.breyer@ukr.de   
Sub-Investigator: Johannes Breyer, MD         
Principal Investigator: Maximillian Burger, MD         
Italy
Humanitas University - Gradenigo Hospital of Turin Recruiting
Turin, Italy
Contact: Alessandro Giacobbe, MD    0039 3474795851    alessandrogiacobbe@yahoo.it   
Sub-Investigator: Alessandro Giacobbe, MD         
Principal Investigator: Giovanni Muto, Prof         
Netherlands
Academic Medical Center Recruiting
Amsterdam, Netherlands, 1105 AZ
Contact: Alice Bakker, nurse    +31 (0)20 5666004    a.d.bakker@amc.uva.nl   
Principal Investigator: Theo De Reijke, Prof         
Spain
Fundacio Puigvert Recruiting
Barcelona, Spain, 08025
Contact: Joan Palou, Prof    0034 93 416 97 00    jpalou@fundacio-puigvert.es   
Principal Investigator: Joan Palou, Prof         
Sweden
Sahlgrenska University Hospital Recruiting
Göteborg, Sweden, 41345
Contact: Viveka Strock, MD    +46-31-3429009    viveka.strock@vgregion.se   
Principal Investigator: Viveka Strock, MD         
Sub-Investigator: Henrik Kjolhede, MD         
United Kingdom
Royal Surrey County Hospital Recruiting
Guildford, United Kingdom, GU2 7XX
Contact: Sally Bradfield, nurse       sally.bradfield@nhs.net   
Principal Investigator: Hugh Mostafid, Prof         
Sponsors and Collaborators
Cepheid
Axonal Biostatem CRO
Investigators
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Principal Investigator: Bernard Malavaud, M.D. CHU Toulouse / Institut Universitaire du Cancer Toulouse Oncopole

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Responsible Party: Cepheid
ClinicalTrials.gov Identifier: NCT03664258     History of Changes
Other Study ID Numbers: ANTICIPATE X
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases