Evaluating a New Test for Bladder Cancer in Patients with Microscopic Hematuria
This study is testing a new way to detect bladder cancer (BCa) non-invasively. Researchers are evaluating a multiplex ELISA assay, which is a type of lab test, using urine samples from people who have microscopic hematuria (blood in the urine that can only be seen under a microscope). The goal is to see if this new test can accurately identify bladder cancer, which is currently often missed by other urine tests. The study aims to enroll about 900 participants aged 18 to 90 years old who have had microscopic hematuria within the last three months and are willing to give their consent. Success will be measured by how well the test's sensitivity and specificity (its ability to correctly identify those with and without bladder cancer) are confirmed by a cystoscopy (an invasive procedure where a camera is inserted into the bladder) after one year. The current recruitment status is unclear.
- Study design
- This is an observational study, meaning researchers will observe and collect data without providing any specific intervention. It aims to enroll approximately 900 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint, which measures the test's accuracy, will be assessed at 1 year.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Novel Multiplex ELISA Assay for Evaluating Patients With Microscopic Hematuria for Bladder Cancer
At a glance
Conditions
NCT03193541
Where you'd take part
This study runs at 8 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Cedars-Sinai Medical Center
Los Angeles, Californiastudy coordinator listed
Recruiting
Hoag Memorial Hospital Presbyterian
Newport Beach, Californiastudy coordinator listed
Recruiting
UCLA Medical Center
Los Angeles, Californiastudy coordinator listed
Recruiting
University of Rochester Medical Center
Rochester, New Yorkstudy coordinator listed
Recruiting
UT Southwestern Medical Center at Dallas
Dallas, Texasstudy coordinator listed
Recruiting
VA Long Beach Healthcare System
Long Beach, Californiastudy coordinator listed
Recruiting
Nara Medical University
Nara, Japanno site contact published
Recruiting
Nara Prefecture Seiwa Medical Center
Nara, Nara, Japanno site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Charles Rosser, MD · STUDY_DIRECTOR · Nonagen Bioscience Corporation
- Hideki Furuya, PhD · PRINCIPAL_INVESTIGATOR · Cedars-Sinai Medical Center
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Want this trial checked against your situation?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Sensitivity and specificity of multiplex ELISA assay will be confirmed by cystoscopy.1 year