Clinical trial NCT03193528: A Novel Multiplex ELISA Assay for Evaluating Patients With Gross Hematuria for Bladder Cancer
Official title: A Novel Multiplex ELISA Assay for Evaluating Patients With Gross Hematuria for Bladder Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bladder Cancer
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: Fred Hutchinson Cancer Center
name: University of Texas
name: Nara Medical University
name: University of California, Los Angeles
name: Nonagen Bioscience Corporation
name: National Cancer Institute (NCI)
name: University of Rochester
name: Nara Prefecture Seiwa Medical Center
First posted: 2017-06-20
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults, age 18 and older who have documented gross hematuria within the past 3 months who are referred for cystoscopy and are willing to participate

Brief summary: To improve upon the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with gross hematuria.

Detailed description: Hematuria is the most common presentation of BCa with 22% of patients with gross hematuria harboring BCa. VUC is the most widely used urine-based assay for detecting BCa; however, it fails to detect approximately 50% of low-grade or early stage BCa when it is most curable.

Because of this severe limitation, patients with hematuria (microscopic or gross) will undergo an invasive examination of the urinary bladder, where a miniature camera is inserted into the bladder. We propose to improve upon the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with gross hematuria.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Have documented or reported gross hematuria within 3 month of study enrollment
* Willing and able to give written informed consent

Exclusion Criteria (patients must not):

* Have history of BCa
* History of previous cancer (excluding 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 hematuria evaluation (i.e., cystoscopy and upper tract imaging)

Primary outcomes:
measure: 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 cohort of 450 participants presenting with gross hematuria.
timeFrame: 1 year
Secondary outcomes:
measure: To compare the sensitivity and specificity of the multiplex ELISA assay to VUC and NMP22® BladderChek to reference standard of cystoscopy in this cohort.
timeFrame: 1 year
measure: 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.
timeFrame: 1 year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Dallas
country: United States
facility: UT Southwestern Medical Center at Dallas
state: Texas
city: Nara
country: Japan
facility: Department of Urology, Nara Medical University
city: Nara
country: Japan
facility: Nara Precfecture Seiwa Medical Center
Study officials:
affiliation: Nonagen Bioscience Corporation
name: Charles Rosser, MD
role: STUDY_DIRECTOR
affiliation: Cedars-Sinai Medical Center
name: Hideki Furuya, MD
role: PRINCIPAL_INVESTIGATOR
References: