SOLUSION: Urine-based Detection of Non-muscle Invasive Bladder

Sponsor
Nessn Azawi (Other)
Overall Status
Recruiting
CT.gov ID
NCT03962933
Collaborator
(none)
533
1
2
91
5.9

Study Details

Study Description

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. 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%).

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Urine test
N/A

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. 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%).

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.

Study Design

Study Type:
Interventional
Anticipated 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
Actual Study Start Date :
Jan 1, 2020
Anticipated Primary Completion Date :
Aug 1, 2025
Anticipated Study Completion Date :
Aug 1, 2027

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Recurrences rate [5 years]

    Recurrences rate

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zealand University Hospital Roskilde Denmark 4000

Sponsors and Collaborators

  • Nessn Azawi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nessn Azawi, Associate professor, Zealand University Hospital
ClinicalTrials.gov Identifier:
NCT03962933
Other Study ID Numbers:
  • SOLUSION
First Posted:
May 24, 2019
Last Update Posted:
Sep 20, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 20, 2021