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The aim of this explorative study is to evaluate whether EpiCheck can be used as a predictor of tumour response to short-term, intensive chemoresection with Mitomycin.
The study will be conducted as an exploratory, prospective observational study. Participants consists of patients referred to short-term, intensive chemoresection due to recurrent NMIBC. The treatment adhere to the regimen described in the NICSA trial with the ClinicalTrials.gov identifier NCT03348969. Treatment consists of short-term, intensive chemoresection with Mitomycin; 40 mg is administered intravesically three times a week for two weeks. To evaluate tumour response, an early cystoscopy is performed in the outpatient clinic one to two months after treatment completion. No visible tumour and residual tumour with benign histology is considered complete response. Residual tumour tissue with neoplastic histology is considered incomplete response and will be treated with TURBT or tumour fulguration. Subsequently patients continue a standardized follow-up program as Danish guidelines prescribe which is initiated after four months.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EpiCheck | Device | If the EpiCheck test is positive at the time of inclusion, the test is repeated prior to the fourth and sixth instillation with Mitomycin as well as prior to the subsequent two cystoscopies. If the EpiCheck test is negative at the time of inclusion, no further tests will be performed. |
| Measure | Description | Time Frame |
|---|---|---|
| EpiCheck result | Number of patients with accordance between EpiCheck score and clinical findings at the time of evaluation cystoscopy | One to two months after short-term, intensive chemoresection |
| Measure | Description | Time Frame |
|---|---|---|
| EpiCheck result 2 | Number of patients with discrepancy between EpiCheck score and clinical findings at the time of cystoscopy | One to two months after short-term, intensive chemoresection |
| EpiCheck result 3 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with a known history of Ta HG with recurrent disease and who are referred to short-term, intensive chemoresection
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria S Lindgren, MD | Contact | 30915431 | 0045 | maalin@rm.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Recruiting | Aarhus | 8200 | Denmark |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Urin samples
Trend of the EpiCheck test over time (increase/decrease/stable score) and its correlation to complete/incomplete tumour response
| One to two months after short-term, intensive chemoresection |
| Urine cytology | Sensitivity, specificity, negative and positive predictive value for urine cytology | One to two months after short-term, intensive chemoresection |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |