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

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2020
INTERVENTION: Method of randomisation: closed envelopes Conventional arm: standard transurethral resection Experimental arm: endoscopic biopsy under local anesthesia with the Urodrill instrument CONDITION: Bladder cancer ; Cancer ; Malignant neoplasm of bladder PRIMARY OUTCOME: 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 SECONDARY OUTCOME: ; 1. Complications from the EndoDrill biopsy procedure assessed by a structured telephone interview 2 weeks after the procedure; 2. Proportion of patients with MIBC that the EndoDrill® Uro X ‐instrument failed to detect, but diagnosed with ordinary TURBT, measured using pathology at [at secondary procedure with TURBT for those in the experimental arm without verification of MIBC and with MIBC verified by TURBT; 3. Proportion of patients with successful molecular classification based on RNA sequencing performed in real time with 6 weeks of sampling in both arms; 4. Cancer‐specific survival (CSS) measured using chart review at 24 months after initiating definitive treatment for MIBC; 5. Overall proportion of patients who correctly followed the protocol and were staged as MIBC in the intervention arm, measured using chart review within 3 months of inclusion; 6. Cost‐effectiveness based on EQ5D5L at baseline and 2 weeks; 7. Quality of life measured using FACT‐G questionnaire preoperatively and FACT‐VCI at 12 months; 8. Adverse events assessed during a phone interview by a research nurse 2 weeks after the procedures; 9. Sensitivity and specificity for CT‐urography and MRI respectively to accurately determine muscle‐invasive bladder cancer compared to the outcome of the combined measure of biopsy and cystectomy specimen, measured using sensitivity calculations compared to pathology within 3 months of inclusion; 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
Epistemonikos ID: 9442442a7295304cf3508a9a396ac43dcf85cc93
First added on: Aug 24, 2024