Bladder Cancer
Conditions
Brief summary
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
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.
Interventions
DEVICEEpiCheck
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.
Sponsors
Aarhus University Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EpiCheck result | One to two months after short-term, intensive chemoresection | Number of patients with accordance between EpiCheck score and clinical findings at the time of evaluation cystoscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EpiCheck result 2 | One to two months after short-term, intensive chemoresection | Number of patients with discrepancy between EpiCheck score and clinical findings at the time of cystoscopy |
| EpiCheck result 3 | One to two months after short-term, intensive chemoresection | Trend of the EpiCheck test over time (increase/decrease/stable score) and its correlation to complete/incomplete tumour response |
| Urine cytology | One to two months after short-term, intensive chemoresection | Sensitivity, specificity, negative and positive predictive value for urine cytology |
Countries
Denmark
Contacts
Primary ContactMaria S Lindgren, MD
Outcome results
None listed