NCT03193515Recruiting
A Novel Multiplex ELISA Assay for Surveilling Patients With History of Bladder Cancer
Source: ClinicalTrials.gov · Last updated 4 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 17 Jun 2017
- Start date
- 30 Dec 2016
- Primary completion date
- 31 Aug 2028
- Lead sponsor
- Cedars-Sinai Medical Center
- Diseases
- Bladder cancer
- NCT number
- NCT03193515
What you commit to
- Study type: Observational
- Planned participants: 300
- From 30 Dec 2016 to the primary completion date, 31 Aug 2028
- 4 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have recent genitourinary instrumentation (within 10 days prior to signing consent)
Other illness
- 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
Lab values
- 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.
Other
- Participants must not:
- Have had radical cystectomy
- Have ureteral stents, nephrostomy tubes or bowel interposition
- Be unable or unwilling to complete the surveillance regimen
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kyoto University Graduate School of Medicine Coordinator of this site? Confirm its status | Kyoto | Japan | Recruiting |
| UT Southwestern Medical Center at Dallas Coordinator of this site? Confirm its status | Dallas | United States | Active, not recruiting |
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.