Urine-based Molecular Testing vs Cystoscopy for Surveillance of Nonmuscle Invasive Bladder Cancer (NMIBC)

Mayo Clinic

Status: Enrolling

Conditions: Non-muscle Invasive Bladder Cancer

Treatments: Diagnostic Test: CxBladder Monitor; Diagnostic Test: Cystoscopy

Study type: Observational

Funder types: Other

Identifiers

NCT06126796

23-008567 (Other Identifier)

NCI-2023-09278 (Registry Identifier)

MDT-CxB-01

Details and patient eligibility

About

The purpose of this study is to evaluate patient-reported preference for urine based molecular testing (CxBladder Monitor) compared to cystoscopy for patients on surveillance for Nonmuscle Invasive Bladder Cancer (NMIBC). Urine based molecular testing involves noninvasive testing of a urine sample for biomarkers associated with disease recurrence. Cystoscopy is an examination of the bladder and urethra using a thin tube like instrument that is inserted into the urethra.

Enrollment: 107 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female with a history of histologically confirmed nonmuscle invasive bladder cancer (NMIBC) who have at least 6 months of disease-free survival from last recurrence.
• Able to provide urine for testing and comply with study protocol.
• Have an email address and be willing to complete surveys online.

Exclusion criteria

• History of non-urothelial bladder cancer (primary squamous, adenocarcinoma, and small cell carcinoma)
• Patients with predominant (>50%) variant histology
• Patients with a history of upper tract and/or urethral cancer
• Women who are pregnant

Trial design

107 participants in 2 patient groups

Arm A: CxBladder followed by cystoscopy

Description:

Arm A will undergo testing with CxBladder 3 months after randomization followed by a cystoscopy 3 months thereafter

Treatment:

Diagnostic Test: Cystoscopy

Diagnostic Test: CxBladder Monitor

Arm B: cystoscopy followed by CxBladder

Description:

Arm B will undergo cystoscopy 3 months after randomization followed by testing with CxBladder 3 months thereafter.

Treatment:

Diagnostic Test: Cystoscopy

Diagnostic Test: CxBladder Monitor