Summary

Eligibility
for people ages 18-90 (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

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.

Details

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.

Keywords

Bladder Cancer, Urinary Bladder Neoplasms, Hematuria

Eligibility

You can join if…

Open to people ages 18-90

  • 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

You CAN'T join if...

(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)

Locations

  • UCLA Medical Center accepting new patients
    Los Angeles California 90095 United States
  • Cedars-Sinai Medical Center accepting new patients
    Los Angeles California 90048 United States
  • VA Long Beach Healthcare System accepting new patients
    Long Beach California 90822 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Cedars-Sinai Medical Center
ID
NCT03193541
Study Type
Observational
Participants
Expecting 900 study participants
Last Updated