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BRIEF TITLE: A Novel Multiplex ELISA Assay for Surveilling Patients With History of Bladder Cancer

A Novel Multiplex ELISA Assay for Surveilling Patients With History of Bladder Cancer


  • Org Study ID: Rosser-2015-6
  • Secondary ID:
  • NCT ID: NCT03193515
  • NCT Alias:
  • Sponsor: University of Hawaii - Other
  • Source: University of Hawaii

Brief Summary

Voided urinary cytology (VUC) is the most widely used urine-based assay for detecting bladder cancer (BCa); however, it fails to detect approximately 50% of low-grade or early stage BCa when it is most curable. Furthermore, the detection rate of VUC for recurrent BCa is not much better. Because of this severe limitation, all patients who are under surveillance to monitor for recurrent BCa must undergo an invasive examination of the urinary bladder, where a miniature camera is inserted into the bladder and the bladder inspected (cystoscopy). We propose to improve the non-invasive detection of recurrent BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples.

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: 2 years

Condition:

  • Bladder Cancer

Eligibility

Criteria:
Inclusion Criteria

Participants must be:

- Age 18 years or older

- Have a history of non-muscle invasive bladder cancer or muscle invasive bladder cancer
treated by bladder sparing techniques (or not yet treated) and diagnosed within the
past 24 months on cystoscopic surveillance

- Participants may be treated with adjuvant intravesical therapy

- Willing and able to give written informed consent (see Appendix 1)

- Be willing to adhere to the surveillance regimen (high risk and intermediate risk seen
every 3 months for 2 years; low risk seen every 6-12 months for 2 years)

Exclusion Criteria:

Participants must not:

- Have had radical cystectomy

- History of previous cancer (excluding bladder, 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 surveillance regimen
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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