Non-muscle Invasive Bladder Cancer (NMIBC)
Conditions
Brief summary
The goal of this clinical trial is to use urine tumor DNA (utDNA) as an indicator for non-muscle invasive bladder cancer to identify patients suitable for less frequent cystoscopy surveillance.
Interventions
DIAGNOSTIC_TESTUroAmp Test (Convergent Genomics, Inc.)
Non-invasive genomic urine test that can reliably detect, monitor, and predict the risk of urothelial cancer or its recurrence, potentially before signs and symptoms develop or become detectable by historical standards of care.
Sponsors
Lahey Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* AUA high-risk bladder cancer1 * Received induction BCG or gemcitabine/docetaxel * Negative initial post-induction therapy assessment (negative cytology and cystoscopy +/- biopsy)
Exclusion criteria
* High-risk NMIBC within 3 years * Prior induction intravesical therapy * Variant histology * Concurrent upper tract disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of cystoscopies | From enrollment to 24 months | The rate of cystoscopies (cystoscopies per month), compared between the De-intensified and the standard surveillance arms, is the primary outcome measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Event-free survival | From enrollment to 24 months | An event is defined as: high-grade recurrence, progression to muscle invasive disease, or metastatic disease |
| Recurrence-free survival | From enrollment to 24 months | We will compare the rate of any recurrences (including low-grade) between the De-intensified and the standard surveillance groups |
| Patient-reported outcomes | From enrollment to 24 months | The National Comprehensive Cancer Network Distress thermometer and the European Organisation For Research And Treatment Of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Non-Muscle Invasive Bladder Cancer (NMIBC-24) Module will be collected and compared between study arms |
Other
| Measure | Time frame | Description |
|---|---|---|
| Interim Analysis | 3 months | After 50% enrollment, the rate of conversion from low-risk on the utDNA test to high risk will be evaluated at 3 months. If this rate exceeds 50%, the study will be terminated for futility. |
Countries
United States
Contacts
Primary ContactLinda Topjian
Backup ContactColette Osborne
Outcome results
None listed