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URINE-BASED DETECTION OF NON-MUSCLE INVASIVE BLADDER CANCER RECURRENCE

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ClinicalTrials.gov Identifier: NCT03962933
Recruitment Status : Not yet recruiting
First Posted : May 24, 2019
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
Zealand University Hospital

Brief Summary:
Non-muscle invasive bladder cancer (NMIBC), which comprises approximately 75% of bladder tumors, has the highest recurrence rate of all cancers, with around 70% of the patients developing local recurrences, despite elaborated treatments 1. Uromonitor is a completely Non-Invasive urine based IVD diagnosis test. It´s able to detect Non-muscle invasive bladder cancer with 100% sensitivity and 97,3 % specificity. Regardless of Tumor stage and grade (unlike Cytology). The rate of Uromonitor false positives (2,3%) is actually lower than the rate of Cystoscopy false positives (3,5%) 9.

Condition or disease Intervention/treatment Phase
Bladder Cancer Diagnostic Test: Urine test Not Applicable

Detailed Description:

Non-muscle invasive bladder cancer (NMIBC), which comprises approximately 75% of bladder tumors, has the highest recurrence rate of all cancers, with around 70% of the patients developing local recurrences, despite elaborated treatments 1. Uromonitor is a completely Non-Invasive urine based IVD diagnosis test. It´s able to detect Non-muscle invasive bladder cancer with 100% sensitivity and 97,3 % specificity. Regardless of Tumor stage and grade (unlike Cytology). The rate of Uromonitor false positives (2,3%) is actually lower than the rate of Cystoscopy false positives (3,5%) 9.

Hypothesis:

The study aims at evaluating the potential clinical impact of a highly sensitive urinary marker, Uromonitor, regarding possible reduction in number of cystoscopies.

We hypothesize that the use of a sensitive urinary marker regarding recurrent tumor will enable us to reduce the number of follow-up cystoscopies without risk of delaying diagnosis of recurrence and progression cystoscopies compared to flexible cystoscopy alone.

We hypothesize that number of tumors missed at follow-up cystoscopy alone or urinary marker alone is identical or in favor of a sensitive urinary marker that can detect sub-visible lesions and the examinations combined identify all tumor recurrences.

Moreover, we hypothesize that tumors missed at follow-up at a given time point are very small and will be identified at next follow-up without increasing the risk of progression and that regular follow-up with cystoscopy alone therefore can be replaced by follow-up with a sensitive urinary biomarker alone - where cystoscopy only is performed if the biomarker is positive.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 533 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: URINE-BASED DETECTION OF NON-MUSCLE INVASIVE BLADDER CANCER RECURRENCE
Estimated Study Start Date : August 1, 2020
Estimated Primary Completion Date : August 1, 2025
Estimated Study Completion Date : August 1, 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Flexcystoscopy
Control cystoscopy every 3 months as a standard procedure
Active Comparator: Uine biomarker
Urine test every 3 months
Diagnostic Test: Urine test
Urine test will be taken every three months after first resection of bladder tumor




Primary Outcome Measures :
  1. Recurrences rate [ Time Frame: 5 years ]
    Recurrences rate



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who previously had low grad NMIBC.
  • No recurrence at cystoscopy at the time of inclusion in the study
  • Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up.

Exclusion Criteria:

  • Clinical suspicion of muscle invasive bladder cancer
  • Upper urinary track tumours
  • Patients undergoing neoadjuvant chemotherapy based on local protocols
  • Metastatic urothelial carcinoma
  • Patients recived installation therapy within the last 4 weeks

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): NCT03962933


Locations
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Denmark
Zealand University Hospital
Roskilde, Denmark, 4000
Sponsors and Collaborators
Zealand University Hospital

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Responsible Party: Zealand University Hospital
ClinicalTrials.gov Identifier: NCT03962933     History of Changes
Other Study ID Numbers: ZUHURO_BL
First Posted: May 24, 2019    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Recurrence
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Disease Attributes
Pathologic Processes