EpiCheck and Short-term Intensive Chemoresection in NMIBC

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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EpiCheck and Short-term Intensive Chemoresection in NMIBC

Conditions
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Bladder Cancer

Intervention / Treatment
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* Device: EpiCheck


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a known history of Ta HG with recurrent disease Patients referred to short-term, intensive chemoresection Patients older than 18 years Exclusion Criteria: Known allergy or intolerance to Mitomycin Incontinence or small bladder capacity (< 100 mL) Previous pelvic radiation therapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: EpiCheck|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |