Assessing the safety and effectiveness of a biopsy instrument when sampling tumours in the urinary bladder

Not Applicable

• Conditions: Bladder cancer; Cancer; Malignant neoplasm of bladder

• Registration Number: ISRCTN80990426
• Lead Sponsor: Skåne University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-10
• Last Update Posted: 15 January 2024
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

1. Provision of written informed consent
2. =18 years of age
3. Patients attending participating urology departments for haematuria investigation and CT-urography suspicious of muscle-invasive bladder cancer

Exclusion Criteria

1. Patients unable or unwilling to undergo EndoDrill biopsy
2. Bleeding diathesis prohibiting EndoDrill biopsies
3. Ongoing immunosuppression (except corticosteroids in moderate doses, less than 10 mg prednisolone or equivalent daily)
4. Patients not suitable/fit for radical treatment for MIBC
5. Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time from radiological suspicion of MIBC to start of definitive treatment for MIBC (neoadjuvant chemotherapy and/or cystectomy): measured using prospective registration at day for radiological report stating suspicion of MIBC to starting day of neoadjuvant chemotherapy, or cystectomy for those operated without neoadjuvant chemotherapy by prospective registration