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

Cedars-Sinai Medical Center

Status: Enrolling

Conditions: Bladder Cancer

Study type: Observational

Funder types: Other; Other U.S. Federal agency; Industry; NIH

Identifiers

NCT03193541

Rosser-2015-8

R01CA198887 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 900 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)