NCT04162704

EpiCheck and Short-term Intensive Chemoresection in NMIBC

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 22 (estimated)
• Sponsor: Aarhus University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-10-28
• Primary completion: 2022-10-01
• Completion: 2022-10-01
• First posted: 2019-11-14
• Last updated: 2021-08-11

Locations

1 site across 1 country: Denmark

Regulatory

• FDA-regulated device study