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BRIEF TITLE: A Novel Multiplex ELISA Assay for Evaluating Patients With Gross Hematuria for Bladder Cancer

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


  • Org Study ID: Rosser-2015-7
  • Secondary ID:
  • NCT ID: NCT03193528
  • NCT Alias:
  • Sponsor: University of Hawaii - Other
  • Source: University of Hawaii

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.

Overal Status Start Date Phase Study Type
Recruiting December 30, 2016 N/A Observational

Primary Outcomes:

Primary Outcome 1 - 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.

Primary Outcome 1 - Time Frame: 1 year

Condition:

  • Bladder Cancer

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)
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Name: Charles Rosser, MD

Phone: 808-586-2979

Email: cjrosser@hawaii.edu

Location

Facility Status Contact
University of Hawaii Cancer Center
Honolulu, Hawaii 96813
United States
Recruiting Charles Rosser, MD
808-586-2979