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

Lahey Health

Status: Enrolling

Conditions: Non-muscle Invasive Bladder Cancer (NMIBC)

Treatments: Diagnostic Test: UroAmp Test (Convergent Genomics, Inc.)

Study type: Interventional

Funder types: Other

Identifiers

NCT07187063

20233622

Details and patient eligibility

About

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.

Enrollment: 56 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

De-Intensified Arm

Experimental group

Description:

Less-frequent cystoscopy surveillance

Treatment:

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

Standard Surveillance Arm

No Intervention group

Description:

Regular follow-ups and standard care