NCT05347342Active, not recruiting
A Diagnostic for the Early Detection of Bladder Cancer
A Novel Multiplex Immunoassay for the Early Detection of Bladder Cancer
Source: ClinicalTrials.gov · Last updated 3 Feb 2026
Brief summary (registry, in English)
To improve upon the non-invasive detection of bladder cancer by further validating a multiplex ELISA assay directed at a bladder cancer-associated diagnostic signature in voided urine samples of patients with a high risk of developing bladder cancer.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 173 (actual)
- First submitted
- 20 Apr 2022
- Start date
- 29 Apr 2022
- Primary completion date
- 31 Jan 2029
- Lead sponsor
- Cedars-Sinai Medical Center
- Diseases
- Bladder cancer
- NCT number
- NCT05347342
What you commit to
- Study type: Observational
- Participants enrolled: 173
- From 29 Apr 2022 to the primary completion date, 31 Jan 2029
- 2 sites in 1 country
- 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
- Previous history of bladder cancer
- A recent genitourinary instrumentation (within 7 days prior to collection of voided urine sample)
Other illness
- History of hematuria (microscopic or gross) within 2 years of signing consent.
- A known active urinary tract infection or urinary retention
Lab values
- An active stone disease (renal or bladder) or renal insufficiency (creatinine \>2.0 mg/dL) - Serum creatinine value can be up to 2 years before consent, otherwise repeat.
Other
- Participants must not have:
- An ureteral stents, nephrostomy tubes or bowel interposition
Who the study is looking for
- Participants must be:
- Age 50 years or older
- \>20 pack year history of tobacco exposure
- Free of any malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years. Patients with localized prostate cancer who are being followed by an active surveillance program are also eligible.
- Scheduled to be evaluated in the Pulmonary Rehab Clinic or Lung Cancer Screening Clinic
- Willing and able to give written informed consent
- Willing to provide voided urine sample
- Be able and willing to complete semi-annual research clinic visits for 4 years
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Long Beach VA Healthcare System Coordinator of this site? Confirm its status | Long Beach | United States | Unknown status |
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.