EpiCheck and Short-term Intensive Chemoresection in NMIBC

NCT ID: NCT04162704

Last Updated: 2021-08-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 22 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-28
• Study Completion Date: 2022-10-31

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.

Conditions

Bladder Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Maria Skydt Lindgren

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Aarhus University Hospital

Aarhus, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Maria S Lindgren, MD

Role: CONTACT

maalin@rm.dk

30915431 ext. 0045

Facility Contacts

Maria S Lindgren, MD

Role: primary

maalin@rm.dk

30915431 ext. 0045

Other Identifiers

1-10-72-207-19

Identifier Type: -

Identifier Source: org_study_id