# MULTIPLEXED PROTEIN BIOMARKER-BASED ASSAY FOR THE DETECTION OF BLADDER CANCER

> **NIH NIH R01** · CEDARS-SINAI MEDICAL CENTER · 2022 · $651,538

## Abstract

Project Summary/Abstract
Background Microscopic hematuria (blood in urine) may occur in up to 10% of the general population and
results in costly evaluation to ensure it is of no consequence, i.e., no bladder cancer (BCa) is present since
hematuria is typically the initial sign of BCa. Furthermore, 75% of patients with newly diagnosed BCa have non-
muscle-invasive disease (NMIBC), which has a very high recurrence rate (>70%). Because of this, it is
recommended that the patients have adjuvant intravesical bacillus Calmette-Guerin (BCG) instillation to reduce
this risk. Despite BCG treatment, up to 50% of patients fail to respond and 20% progress to muscle invasive
bladder cancer (MIBC) mandating more radical treatment (i.e., cystectomy - removal of the urinary bladder).
Moreover, the delay in radical treatment can negatively impact survival rates, hence, a test that could predict
treatment response to intravesical BCG, ensuring the right patient, gets the right treatment at the right time is
urgently required. To date, no such test is available. There exists an unmet clinical need for reliable biomarkers
to a) ‘rule out’ which patients with microscopic hematuria do not require further evaluation and b) predict which
patients will respond to BCG. Hypothesis Our central hypothesis is that a molecular profile exists that is
specifically associated with BCa that a) can be utilized to indicate the presence of BCa in non-invasively
obtained urine samples and b) can be utilized to predict response to BCG. This hypothesis will be tested by
completing the following Specific Aims: 1) To validate the multiplex immunoassay for BCa detection in
subjects presenting with microscopic hematuria, 2) To evaluate the cost benefit, cost utility and cost
effectiveness of the multiplex immunoassay in subjects with hematuria and a history of BCa on tumor
surveillance and 3) To validate prospectively the urine-based multiplex immunoassay to predict BCG response
in subjects with intermediate/high risk NMIBC. Significance This research will open the door for improving on
the non-invasive methods for detecting BCa and predicting treatment response as such it will have a
marked impact on patient care. Methodology Our group has developed and tested a multiplex immunoassay
towards a BCa signature with extremely encouraging results in subjects evaluated for gross hematuria and a
history of BCa on tumor surveillance. In the current proposal, we now seek to test the multiplex assay in two
additional independent cohorts: intermediate/high-risk patients (AUA microscopic hematuria guidelines 2020)
presenting with microscopic hematuria for early BCa detection and patients with intermediate/high risk NMIBC
treated with intravesical BCG to predict treatment response. Furthermore, we will generate Markov models and
using data collected from the parent R01 to assess cost benefit, cost utility and cost effectiveness of the
multiplex immunoassay. Expected Results The validation of the multi...

## Key facts

- **NIH application ID:** 10462772
- **Project number:** 5R01CA198887-07
- **Recipient organization:** CEDARS-SINAI MEDICAL CENTER
- **Principal Investigator:** Charles J Rosser
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $651,538
- **Award type:** 5
- **Project period:** 2016-05-01 → 2026-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10462772

## Citation

> US National Institutes of Health, RePORTER application 10462772, MULTIPLEXED PROTEIN BIOMARKER-BASED ASSAY FOR THE DETECTION OF BLADDER CANCER (5R01CA198887-07). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10462772. Licensed CC0.

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