NCT03193528Completed
A Novel Multiplex ELISA Assay for Evaluating Patients With Gross Hematuria for Bladder Cancer
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
To improve upon the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with gross hematuria.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 450 (actual)
- First submitted
- 17 Jun 2017
- Start date
- 30 Dec 2016
- Primary completion date
- 13 Aug 2026
- Lead sponsor
- Cedars-Sinai Medical Center
- Diseases
- Bladder cancer
- NCT number
- NCT03193528
What you commit to
- Study type: Observational
- Participants enrolled: 450
- From 30 Dec 2016 to the primary completion date, 13 Aug 2026
- 6 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
- Have history of BCa
- History of previous cancer (excluding 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
- Have ureteral stents, nephrostomy tubes or bowel interposition
- Be unable or unwilling to complete the hematuria evaluation (i.e., cystoscopy and upper tract imaging)
Who the study is looking for
- Age 18 years or older
- Have documented or reported gross hematuria within 3 month of study enrollment
- Willing and able to give written informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Urology, Nara Medical University Coordinator of this site? Confirm its status | Nara | Japan | Unknown status |
| Nara Precfecture Seiwa Medical Center Coordinator of this site? Confirm its status | Nara | Japan | Unknown status |
| UT Southwestern Medical Center at Dallas Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| University of California, Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| University of Rochester Medical Center Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.