A Novel Multiplex ELISA Assay for Surveilling Patients With History of Bladder Cancer

Study Overview
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Brief Summary
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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.

Official Title
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A Novel Multiplex ELISA Assay for Surveilling Patients With History of Bladder Cancer

Conditions
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Bladder Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Participants must be: Age 18 years or older Have a history of non-muscle invasive bladder cancer or muscle invasive bladder cancer treated by bladder sparing techniques (or not yet treated) and diagnosed within the past 24 months on cystoscopic surveillance Participants may be treated with adjuvant intravesical therapy Willing and able to give written informed consent (see Appendix 1) Be willing to adhere to the surveillance regimen (high risk and intermediate risk seen every 3 months for 2 years; low risk seen every 6-12 months for 2 years) Exclusion Criteria: Participants must not: Have had radical cystectomy History of previous cancer (excluding bladder, basal and squamous cell skin cancer) within the past 3 years Have a known active urinary tract infection or urinary retention Have active stone disease (renal or bladder) or renal insufficiency (creatinine >2.0 mg/dL) - Serum creatinine value can be up to 60 days before consent, otherwise repeat. Have ureteral stents, nephrostomy tubes or bowel interposition Have recent genitourinary instrumentation (within 10 days prior to signing consent) Be unable or unwilling to complete the surveillance regimen

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 years |