This study is in progress, not accepting new patients

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

a study on Bladder Cancer Urinary Bladder Tumor

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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.

Keywords

Bladder Cancer, Urinary Bladder Neoplasms

Eligibility

You can join if…

Open to people ages 18 years and up

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)

You CAN'T join if...

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

Locations

  • UCSF
    San Francisco California 94158 United States
  • Cedars-Sinai Medical Center
    Los Angeles California 90048 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Charles Rosser
ID
NCT03193515
Study Type
Observational
Participants
About 300 people participating
Last Updated