Actively Recruiting
A Novel Multiplex ELISA Assay for Surveilling Patients With History of Bladder Cancer
Led by Cedars-Sinai Medical Center · Updated on 2026-02-04
300
Participants Needed
4
Research Sites
604 weeks
Total Duration
On this page
Sponsors
C
Cedars-Sinai Medical Center
Lead Sponsor
F
Fred Hutchinson Cancer Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Novel Multiplex ELISA Assay for Surveilling Patients With History of Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- History of non-muscle invasive or muscle invasive bladder cancer treated by bladder sparing techniques (or not yet treated) diagnosed within the past 24 months on cystoscopic surveillance
- May be treated with adjuvant intravesical therapy
- Willing and able to give written informed consent
- Willing to adhere to surveillance regimen (high and intermediate risk every 3 months for 2 years; low risk every 6-12 months for 2 years)
You will not qualify if you...
- Prior radical cystectomy
- History of previous cancer (excluding bladder, basal and squamous cell skin cancer) within the past 3 years
- Known active urinary tract infection or urinary retention
- Active stone disease (renal or bladder) or renal insufficiency (creatinine >2.0 mg/dL)
- Presence of ureteral stents, nephrostomy tubes, or bowel interposition
- Recent genitourinary instrumentation within 10 days before consent
- Unable or unwilling to complete the surveillance regimen
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
2
University of California San Francisco
San Francisco, California, United States, 94158
Active, Not Recruiting
3
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390
Active, Not Recruiting
4
Kyoto University Graduate School of Medicine
Kyoto, Japan
Actively Recruiting
Research Team
C
Charles Rosser, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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