免费获得国外相关药品，最快 1 个工作日回馈药物信息
Urine-based Detection of Non-muscle Invasive Bladder (SOLUSION)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Bladder Cancer | Diagnostic Test: Urine test | Not Applicable |
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 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 |
| Actual Study Start Date : | January 1, 2020 |
| Estimated Primary Completion Date : | August 1, 2025 |
| Estimated Study Completion Date : | August 1, 2027 |
| 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
|
- Recurrences rate [ Time Frame: 5 years ]Recurrences rate
| Ages Eligible for Study: | Child, Adult, Older Adult |
| 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
| Denmark | |
| Zealand University Hospital | Recruiting |
| Roskilde, Denmark, 4000 | |
| Contact: Nessn H. Azawi, M.D. 004526393034 nesa@regionsjaelland.dk | |
| Principal Investigator: Nessn Azawi, Ph.D | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 23, 2019 | ||||
| First Posted Date ICMJE | May 24, 2019 | ||||
| Last Update Posted Date | July 15, 2020 | ||||
| Actual Study Start Date ICMJE | January 1, 2020 | ||||
| Estimated Primary Completion Date | August 1, 2025 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Recurrences rate [ Time Frame: 5 years ] Recurrences rate
|
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Urine-based Detection of Non-muscle Invasive Bladder | ||||
| Official Title ICMJE | Urine-based Detection of Non-muscle Invasive Bladder Cancer Recurrence | ||||
| 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%). | ||||
| 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 Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Diagnostic |
||||
| Condition ICMJE | Bladder Cancer | ||||
| Intervention ICMJE | Diagnostic Test: Urine test
Urine test will be taken every three months after first resection of bladder tumor
|
||||
| Study Arms ICMJE |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
533 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | August 1, 2027 | ||||
| Estimated Primary Completion Date | August 1, 2025 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||
| Sex/Gender ICMJE |
|
||||
| Ages ICMJE | Child, Adult, Older Adult | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | |||||
| Listed Location Countries ICMJE | Denmark | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03962933 | ||||
| Other Study ID Numbers ICMJE | SOLUSION | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
||||
| IPD Sharing Statement ICMJE |
|
||||
| Responsible Party | Nessn Azawi, Zealand University Hospital | ||||
| Study Sponsor ICMJE | Nessn Azawi | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Zealand University Hospital | ||||
| Verification Date | July 2020 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||
