CxBladder Surveillance of Intermediate and High-Risk Bladder Cancer Patients

Launched by PACIFIC EDGE LIMITED · Oct 5, 2021

Keywords

ClinConnect Summary

The clinical trial titled "CxBladder Surveillance of Intermediate and High-Risk Bladder Cancer Patients" is exploring a new way to monitor patients for the recurrence of urothelial bladder cancer. Currently, patients often have to undergo frequent and invasive procedures called cystoscopies to check for cancer recurrence. This study is testing a urine test called CxBladder, which could reduce the need for these procedures by identifying cancer recurrence through urine samples. Participants will need to provide urine samples at four visits and will be monitored closely throughout the study.

To be eligible for this trial, participants must be at least 18 years old and have a previous diagnosis of urothelial carcinoma (bladder cancer). They should be classified as high or intermediate risk for recurrence and must be able to provide urine samples on their own. However, those who have had certain recent medical procedures or specific types of bladder surgery might not qualify. If you join the study, you can expect to contribute urine samples during your visits and have your medical records reviewed to help researchers understand the effectiveness of this new test.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. High and intermediate risk surveillance subjects with a previous confirmed diagnosis or recurrence of urothelial carcinoma
• • 2. Subjects must agree to 4 successive visits including urine sample collection at each of the study visits and records review follow-up
• • 3. Able to provide a voided urine sample (a sample from catheterization is not eligible) of the required minimum volume
• • 4. Able to give written consent
• • 5. Able and willing to comply with study requirements
• • 6. Aged 18 years or older
• Exclusion Criteria:
• • 1. Prior genitourinary manipulation (flexible or rigid cystoscopy / catheterization, urethral dilation) in the 14 days before urine collection
• • 2. Total cystectomy of the bladder, subjects with neo-bladders or illeal conduits
• • 3. Previous muscle invasive bladder tumour (pT2 or greater)
• • 4. Pregnancy