Bladder Cancer Clinical Trial
Official title:
Biomarker Discovery and Application in Bladder Cancer: Identification and Detection of Gene Methylation, Tumor Specific Antigenes Markers of BCG Treatment.
The investigators' long-term objective is to research and develop innovative new tests which
diagnostic laboratories can use to 1) detect methylated DNA targets, 2) tumor specific
antigens, and 3) markers of Bacillus Calmette-Guerin (BCG) treatment in patient urine
samples. The investigators plan to detect methylated DNA targets and control targets by
methylation-specific polymerase chain reaction (msPCR) on DNA isolated from urine samples
from bladder cancer positive and negative patients to determine its sensitivity and
specificity in detecting bladder cancer. The investigators plan to use patient sera as a
tool to detect tumor specific antigens expressed by bladder cancer cell lines. Once a
bladder tumor specific protein is identified, the investigators will assess its presence in
the urine of bladder cancer patients and absence in healthy patients by enzyme-linked
immunosorbent assay (ELISA). The investigators plan to use both in vitro models and patient
clinical samples to elucidate the role of bladder epithelial cells in mediating BCG
immunotherapy and identify biomarkers of treatment effectiveness. Once a biomarker is
identified, the investigators will assess its presence in the urine of bladder cancer and
absence in healthy patients.
Once the investigators determine the feasibility of these tests, the investigators will
further perform an extensive clinical study, comparing the tests to existing diagnostic
methods. This study will provide the foundation for FDA approval, which is required for
tests to become widely accepted tools for clinicians to use in bladder cancer diagnosis. The
investigators' tests will improve early detection of bladder cancer, thereby improving
patient health and decrease cancer deaths, a key mission of the National Institutes of
Health.
n/a
Observational Model: Cohort, Time Perspective: Prospective
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