EpiCheck and Short-term Intensive Chemoresection in NMIBC

Bladder Cancer Clinical Trial

Official title:

EpiCheck and Short-term Intensive Chemoresection in NMIBC

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04162704
• Other study ID #: 1-10-72-207-19
• Status: Recruiting
• Start date: October 28, 2019
• Est. completion date: October 2022

Study information

• Verified date: August 2021
• Source: Aarhus University Hospital
• Contact: Maria S Lindgren, MD
• Phone: 30915431
• Email: maalin[@]rm.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Urine cytology	Sensitivity, specificity, negative and positive predictive value for urine cytology	One to two months after short-term, intensive chemoresection