Using Urine Tumor DNA to De-Intensify Surveillance in Non-Muscle Invasive Bladder Cancer

ConditionNon-muscle Invasive Bladder Cancer (NMIBC)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorLahey Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

AUA high-risk bladder cancer1

Received induction BCG or gemcitabine/docetaxel

Negative initial post-induction therapy assessment (negative cytology and cystoscopy +/- biopsy)

Disqualifiers

High-risk NMIBC within 3 years

Prior induction intravesical therapy

Variant histology

Concurrent upper tract disease

Trial design

Design model

Parallel

Treatments tested in this trial

UroAmp Test (Convergent Genomics, Inc.)
Diagnostic test
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.

Treatment groups

56 Participants

are divided into 2 treatment groups

Group A: De-Intensified ArmExperimental treatment 1 intervention

Group B: Standard Surveillance ArmNo intervention 0 interventions

Trial outcomes

Primary outcomes

Number of cystoscopies

The rate of cystoscopies (cystoscopies per month), compared between the De-intensified and the standard surveillance arms, is the primary outcome measure.

Time frame

From enrollment to 24 months

Secondary outcomes

Event-free survival

An event is defined as: high-grade recurrence, progression to muscle invasive disease, or metastatic disease

Time frame

From enrollment to 24 months

Recurrence-free survival

We will compare the rate of any recurrences (including low-grade) between the De-intensified and the standard surveillance groups

Time frame

From enrollment to 24 months

Patient-reported outcomes

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

Time frame

From enrollment to 24 months

Other outcomes

Interim Analysis

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.

Time frame

3 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lahey Clinic

Lead sponsor

Source ClinicalTrials.gov

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