Clinical trial NCT03193541: A Novel Multiplex ELISA Assay for Evaluating Patients With Microscopic Hematuria for Bladder Cancer
Official title: A Novel Multiplex ELISA Assay for Evaluating Patients With Microscopic Hematuria for Bladder Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bladder Cancer
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: Nonagen Bioscience Corporation
name: Nara Medical University
name: University of California, Los Angeles
name: University of Rochester
name: National Cancer Institute (NCI)
name: University of Texas, Southwestern Medical Center at Dallas
name: VA Long Beach Healthcare System
name: Nara Prefecture Seiwa Medical Center
First posted: 2017-06-20
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults, age 18 and older who have documented microscopic 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 microscopic hematuria.

Detailed description: Hematuria is the most common presentation of BCa with 8% of patients with microscopic 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 will undergo an invasive examination of the urinary bladder, where a miniature camera is inserted into the bladder.

We propose to improve 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 microscopic hematuria.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria (participants must not):

* Have history of BCa
* History of previous cancer (excluding basal and squamous cell skin cancer)
* 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)
* 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: Sensitivity and specificity of multiplex ELISA assay will be confirmed by cystoscopy.
timeFrame: 1 year
Secondary outcomes:
measure: Sensitivity and specificity of multiplex ELISA assay will be compared to VUC and NMP-22 BladderChek.
timeFrame: 1 year
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: VA Long Beach Healthcare System
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
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: Nara Prefecture Seiwa Medical Center
city: Nara
country: Japan
facility: Nara Medical University
Study officials:
affiliation: Nonagen Bioscience Corporation
name: Charles Rosser, MD
role: STUDY_DIRECTOR
affiliation: Cedars-Sinai Medical Center
name: Hideki Furuya, PhD
role: PRINCIPAL_INVESTIGATOR
References: