NCT03193515 · Cedars-Sinai Medical Center
A Novel Multiplex ELISA Assay for Surveilling Patients With History of Bladder Cancer
What this study 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Los Angeles, California
- San Francisco, California
- Dallas, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 4, 2026 · Source of record for eligibility and locations