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
|Condition or disease||Intervention/treatment|
|Non-muscle-invasive Bladder Cancer||Diagnostic Test: Xpert Bladder Cancer Monitor|
|Study Type :||Observational|
|Estimated Enrollment :||1100 participants|
|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|
- 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).
- 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).
- 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.
- 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.
- 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).
- 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.
- 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
- 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.
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
|Contact: Laura Fabre, PharmD||+33 563 825 email@example.com|
|Contact: Anne Postulka, M.D.||+33 5 63 82 53 firstname.lastname@example.org|
|Medical University of Vienna||Recruiting|
|Vienna, Austria, A-1090|
|Contact: Kilian Gust, MD +43 1 40400 26150 email@example.com|
|Sub-Investigator: Kilian Gust, MD|
|Principal Investigator: Shahrokh Shariat, Prof|
|Teaching Hospital Motol||Recruiting|
|Contact: Barbora Provaznikova +420224434848 firstname.lastname@example.org|
|Principal Investigator: Antonin Brisuda, MD|
|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|
|University of Regensburg||Recruiting|
|Regensburg, Germany, 93053|
|Contact: Johannes Breyer, MD +49 941 782 3534 email@example.com|
|Sub-Investigator: Johannes Breyer, MD|
|Principal Investigator: Maximillian Burger, MD|
|Humanitas University - Gradenigo Hospital of Turin||Recruiting|
|Contact: Alessandro Giacobbe, MD 0039 3474795851 firstname.lastname@example.org|
|Sub-Investigator: Alessandro Giacobbe, MD|
|Principal Investigator: Giovanni Muto, Prof|
|Academic Medical Center||Recruiting|
|Amsterdam, Netherlands, 1105 AZ|
|Contact: Alice Bakker, nurse +31 (0)20 5666004 email@example.com|
|Principal Investigator: Theo De Reijke, Prof|
|Barcelona, Spain, 08025|
|Contact: Joan Palou, Prof 0034 93 416 97 00 firstname.lastname@example.org|
|Principal Investigator: Joan Palou, Prof|
|Sahlgrenska University Hospital||Recruiting|
|Göteborg, Sweden, 41345|
|Contact: Viveka Strock, MD +46-31-3429009 email@example.com|
|Principal Investigator: Viveka Strock, MD|
|Sub-Investigator: Henrik Kjolhede, MD|
|Royal Surrey County Hospital||Recruiting|
|Guildford, United Kingdom, GU2 7XX|
|Contact: Sally Bradfield, nurse firstname.lastname@example.org|
|Principal Investigator: Hugh Mostafid, Prof|
|Principal Investigator:||Bernard Malavaud, M.D.||CHU Toulouse / Institut Universitaire du Cancer Toulouse Oncopole|