Longitudinal Bladder Cancer Study for Tumour Recurrence

Conditions

• Urothelial Bladder Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• CxBladder Monitor/Monitor+ — DIAGNOSTIC_TEST
  CxBladder Monitor/Monitor+ is a high sensitivity and negative predictive value (NPV) urinary biomarker test to rule-out subjects at low risk of bladder cancer monitoring for recurrence of disease.

Study Details

Surveillance for recurrence of urothelial carcinoma (UC) requires frequent cystoscopy, which is invasive, expensive and time-consuming. An accurate urinary biomarker has the potential to reduce the number of cystoscopies required during post-treatment surveillance. This is a prospective, single arm, multi-center study using the diagnostic CxBladder test with subjects previously diagnosed with primary or recurrent UC and who are undergoing a schedule of investigative cystoscopies and treatment for the possible recurrence of UC presenting to qualified sites. To evaluate the performance characteristics of the CxBladder test, multiple consecutive urine samples will be collected during the course of surveillance.

Key Dates

Start date

Jun 8, 2022

Status verified

Dec 2024

Primary completion

May 30, 2026

Completion

Aug 31, 2026

Study Design

Enrollment

450 participants (estimated)

Arms

• Arm: Single arm - Patients undergoing surveillance for UC recurrence
  Subjects previously diagnosed with UC and are undergoing a schedule of surveillance cystoscopies and treatment for the possible recurrence of UC will be recruited. Low-, intermediate-, and high-risk groups, according to AUA /SUO risk categorisation for non-muscle invasive UC, will be eligible for this study. All subjects will undergo CxBladder urine diagnostic testing.

Primary Outcome Measure

To clinically validate the performance characteristics of CxBladder Monitor/Monitor+ [ Time Frame: 12 Months ]

Central Contacts

• Donna Smith, MSc (Hons)
  +64 21 243 6696
  [email protected]
• Alexis White
  +64 21 959 001
  [email protected]

Locations (6)

Find similar trials in Miami, FL

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