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BRIEF TITLE: ELISA Assay for Evaluating Patients With Microscopic Hematuria for Bladder Cancer

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


  • Org Study ID: Rosser-2015-8
  • Secondary ID:
  • NCT ID: NCT03193541
  • 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 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.

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

Primary Outcomes:

Primary Outcome 1 - Measure: Sensitivity and specificity of multiplex ELISA assay will be confirmed by cystoscopy.

Primary Outcome 1 - Time Frame: 1 year

Condition:

  • Bladder Cancer

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)
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers:

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