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)

NCT03664258 | Completed DMC

• 1 other identifier: ANTICIPATE X
• Study Type: observational
• Target: 852
• Locations: 9 countries
• Sites: 13

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).

Conditions

Non-muscle-invasive Bladder Cancer

Outcome Measures

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

  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 Outcomes (6)

• 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.

  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.

  At each patient follow-up up to 12 months of study.

• EuroQol Five Dimensions Questionnaire (EQ-5D-5L questionnaire) at Day 0

  At patient enrollment

• Patient numeric scale for cystoscopy discomfort

  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.

  1 month after each cystoscopy through study completion.

Interventions

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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),
• years or older at the time of enrolment,
• Signed informed consent.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Cepheid: lead
• Axonal-Biostatem: collaborator
• Stève Consultants: collaborator

Study Sites (13)

University Clinic for Urology and Andrology

Salzburg, Austria

Location

Medical University of Vienna

Vienna, A-1090, Austria

Location

Teaching Hospital Motol

Prague, Czechia

Location

CHU Toulouse / Institut Universitaire du Cancer Toulouse Oncopole

Toulouse, 31100, France

Location

Klinikum Braunschweig

Braunschweig, Germany

Location

University of Regensburg

Regensburg, 93053, Germany

Location

Humanitas University - Gradenigo Hospital of Turin

Turin, Italy

Location

Academic Medical Center

Amsterdam, 1105 AZ, Netherlands

Location

Fundacio Puigvert

Barcelona, 08025, Spain

Location

Instituto Valenciano de Oncologia

Valencia, Spain

Location

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

Royal Surrey County Hospital

Guildford, GU2 7XX, United Kingdom

Location

Sunderland City Hospital

Sunderland, United Kingdom

Location

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Bernard Malavaud, M.D.

  CHU Toulouse / Institut Universitaire du Cancer Toulouse Oncopole

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2018
• First Posted: September 10, 2018
• Study Start: June 6, 2018
• Primary Completion: December 31, 2021
• Study Completion: January 31, 2022
• Last Updated: February 13, 2023

Record last verified: 2021-08

Locations

IT (1); AU (2); SE (1); GB (2); NL (1); FR (1); ES (2); CZ (1); DE (2)