A Novel Multiplex ELISA Assay for Surveilling Patients With History of Bladder Cancer
Key facts
- Where
- Kyoto, JapanSee the site
Where in Japan
- Kyoto University Graduate School of MedicineKyoto, JapanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Cedars-Sinai Medical Center
- Trial code
- NCT03193515
- Record updated
- 4 February 2026
- Original 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.Read full original descriptionShow less
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.
Inclusion: 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: Have recent genitourinary instrumentation (within 10 days prior to signing consent); 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; Participants must not:; Have had radical cystectomy; Have ureteral stents, nephrostomy tubes or bowel interposition; Be unable or unwilling to complete the surveillance regimen.