A Novel Multiplex ELISA Assay for Evaluating Patients With Microscopic Hematuria for Bladder Cancer

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03193541

Enrollment

900

Registered

2017-06-20

Start date

2016-12-30

Completion date

2029-02-01

Last updated

2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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)

Design outcomes

Primary

Measure	Time frame
Sensitivity and specificity of multiplex ELISA assay will be confirmed by cystoscopy.	1 year

Secondary

Measure	Time frame
Sensitivity and specificity of multiplex ELISA assay will be compared to VUC and NMP-22 BladderChek.	1 year

Countries

Japan, United States

Contacts

CONTACTCharles Rosser, MD

charles.rosser@cshs.org310-423-5609

STUDY_DIRECTORCharles Rosser, MD

Nonagen Bioscience Corporation

PRINCIPAL_INVESTIGATORHideki Furuya, PhD

Cedars-Sinai Medical Center

Outcome results