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.

Study Overview

• Status: Recruiting
• Conditions: Bladder Cancer
• Intervention / Treatment: Device: EpiCheck

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.

• Study Type: Observational
• Enrollment (Anticipated): 22

Contacts and Locations

• Study Contact: Name: Maria S Lindgren, MD; Phone Number: 0045 30915431; Email: maalin@rm.dk

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Recruiting
    • Aarhus University Hospital
    • Contact: Maria S Lindgren, MD; Phone Number: 0045 30915431; Email: maalin@rm.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with a known history of Ta HG with recurrent disease and who are referred to short-term, intensive chemoresection

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Urine cytology	Sensitivity, specificity, negative and positive predictive value for urine cytology	One to two months after short-term, intensive chemoresection

Collaborators and Investigators

• Sponsor: Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2019
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: November 12, 2019
• First Submitted That Met QC Criteria: November 12, 2019
• First Posted (Actual): November 14, 2019

Study Record Updates

• Last Update Posted (Actual): August 11, 2021
• Last Update Submitted That Met QC Criteria: August 10, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: 1-10-72-207-19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No