Voided urinary cytology (VUC) is the most widely used urine-based assay for detecting bladder cancer (BCa); however, it fails to detect approximately 50% of low-grade or early stage BCa when it is most curable. Furthermore, the detection rate of VUC for recurrent BCa is not much better. Because of this severe limitation, all patients who are under surveillance to monitor for recurrent BCa must undergo an invasive examination of the urinary bladder, where a miniature camera is inserted into the bladder and the bladder inspected (cystoscopy). We propose to improve the non-invasive detection of recurrent BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples.
Study Type
OBSERVATIONAL
Enrollment
300
Cedars-Sinai Medical Center
Los Angeles, California, United States
RECRUITINGUniversity of California San Francisco
San Francisco, California, United States
ACTIVE_NOT_RECRUITINGUT Southwestern Medical Center at Dallas
Dallas, Texas, United States
ACTIVE_NOT_RECRUITINGKyoto University Graduate School of Medicine
Kyoto, Japan
RECRUITINGSensitivity and specificity of multiplex ELISA assay will be confirmed by cystoscopy.
To examine the sensitivity and specificity of the multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples to reference standard of cystoscopy in a prospective longitudinal cohort of 300 participants with a history of BCa currently on cancer surveillance.
Time frame: 2 years
Sensitivity and specificity of multiplex ELISA assay will be compared to VUC and NMP22 BladderCheck.
To compare the sensitivity and specificity of the multiplex ELISA assay to VUC and NMP22® BladderChek to reference standard of cystoscopy in this cohort. To develop a BCa risk calculator from this cohort using cutting edge machine learning techniques (e.g., random forest) incorporating biomarker data and clinical data.
Time frame: 2 years
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