# Personalized assessment of bladder cancer treatment response using urinary molecular biomarkers

> **NIH VA I01** · VETERANS ADMIN PALO ALTO HEALTH CARE SYS · 2021 · —

## Abstract

Bladder cancer is the sixth most common cancer in the U.S., has one of the highest recurrence rates of all solid
cancers, and is the most expensive cancer to treat from diagnosis to death. Veterans are at increased risk for
bladder cancer due higher rates of tobacco use and environmental exposure. There are significant unmet needs
for biomarkers and molecular diagnostic tools to better inform decision making across all stages of bladder
cancer. For patients with early stage disease, current diagnostic approaches are either invasive (e.g. cystoscopy)
or lack sensitivity (e.g. urine cytology). We propose to develop molecular diagnostics that will lead to more
effective and personalized therapeutic strategies for patients with localized bladder cancer. Tumor-derived
nucleic acids in biological fluids such as urine represent promising biomarkers for non-invasive measurement of
disease burden and response to therapy. Previously, we developed a pipeline for bladder cancer biomarker
discovery, validation, and technology integration for clinical translation. We applied high throughput RNA
sequencing of urinary sediments as a biomarker discovery tool and identified a urinary mRNA (u-mRNA) panel
with promising diagnostic performance. In parallel, we validated an integrated microfluidics cartridge capable
of “sample-in, answer-out” within 90 minutes using a separate u-mRNA panel. Our recent preliminary data
indicate further improvement of diagnostic performance by combining the two panels within the integrated
cartridge. Based on these promising preliminary data, we propose three specific aims: 1) to validate the
optimized mRNA panel for bladder cancer surveillance and risk stratification; 2) to validate the optimized u-
mRNA panel to improve bladder cancer screening and assess risk stratification; and 3) to validate the optimized
u-mRNA panel for response assessment and monitoring in patients with high risk NMIBC treated with BCG
immunotherapy. Our team is led by experienced academic VA investigators with complimentary expertise in
molecular diagnostics (Liao), urologic oncology (Liao, Leppert), and clinical validation study design (Liao, Yu).
Successful completion of the studies proposed here will serve as a foundation for incorporating urine-based
biomarkers in bladder cancer surveillance and into prospective clinical trials to assess therapeutic interventions.
We foresee that our approach will allow personalization of treatment strategies to improve outcomes for BC
patients in both veterans and the general population.

## Key facts

- **NIH application ID:** 10015540
- **Project number:** 1I01BX004962-01A1
- **Recipient organization:** VETERANS ADMIN PALO ALTO HEALTH CARE SYS
- **Principal Investigator:** JOSEPH C LIAO
- **Activity code:** I01 (R01, R21, SBIR, etc.)
- **Funding institute:** VA
- **Fiscal year:** 2021
- **Award amount:** —
- **Award type:** 1
- **Project period:** 2020-10-01 → 2024-09-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10015540

## Citation

> US National Institutes of Health, RePORTER application 10015540, Personalized assessment of bladder cancer treatment response using urinary molecular biomarkers (1I01BX004962-01A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10015540. Licensed CC0.

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