Testing a New Urine Test to Detect Returning Bladder Cancer
Tests a new urine test to find bladder cancer that has returned.
Plain-language title generated from the registry record
Registry title: A Novel Multiplex ELISA Assay for Surveilling Patients With History of Bladder Cancer
Key facts
- Where
- Kyoto, JapanSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a history of bladder cancer, diagnosed in the past 24 months, who are followed with cystoscopy checks. It tests a urine test for recurrent bladder cancer.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- History of non-muscle invasive bladder cancer, or muscle invasive bladder cancer treated by bladder sparing techniques (or not yet treated), diagnosed within the past 24 months on cystoscopic surveillance.
- Earlier treatment
- Treatment with adjuvant intravesical therapy is allowed. People who have had radical cystectomy cannot join.
Main reasons for not taking part
- Radical cystectomy
- Another cancer in the past 3 years (bladder, basal and squamous cell skin cancer excepted)
- Known active urinary tract infection or urinary retention
- Active stone disease or renal insufficiency (creatinine >2.0 mg/dL (177 µmol/L))
- Ureteral stents, nephrostomy tubes or bowel interposition
Read by machine on 12 November 2026.
Where in Japan
- Kyoto University Graduate School of MedicineKyoto, JapanContact: Yuki Kita, MD, PhDTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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
A Novel Multiplex ELISA Assay for Surveilling Patients With History of Bladder Cancer
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.