EpiCheck and Short-term Intensive Chemoresection in NMIBC
EpiCheck and Short-term Intensive Chemoresection in NMIBC
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.
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