Multiplex ELISA Assay for Bladder Cancer

Recruiting at 7 trial locations

Overseen By Charles Rosser, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: History of cancer, Urinary infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

900 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve early detection of bladder cancer by testing a new method called a novel multiplex ELISA assay, a type of laboratory test that identifies cancer signals in urine samples. It targets individuals who have recently noticed blood in their urine, a condition known as microscopic hematuria (tiny amounts of blood not visible without a microscope). Participants should not have a history of bladder or other significant cancers and should be free of current urinary infections or stones. As a Phase 2 trial, this research measures the effectiveness of the new method in an initial, smaller group, offering a chance to contribute to advancements in early cancer detection.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this novel multiplex ELISA assay is safe for use in detecting BCa?

Research has shown that ELISA tests are safe and reliable in clinical settings. Traditional ELISA is highly trusted for detecting proteins or antigens in samples, consistently providing accurate results.

Multiplex ELISA, which tests for several markers simultaneously, is still undergoing improvements for clinical use. A study on a new type of multiplex ELISA indicated it might accurately measure multiple substances at once. This suggests the technology is promising, but further development is needed before regular clinical use.

No specific reports of safety issues with multiplex ELISA tests exist, suggesting they are generally safe. However, like any new technology, ongoing testing is crucial to ensure safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Novel Multiplex ELISA Assay for evaluating microscopic hematuria because it offers a non-invasive and potentially more accurate way to screen for bladder cancer. Unlike traditional methods like cystoscopy, which can be uncomfortable and invasive, this assay uses a blood test to detect multiple biomarkers associated with cancer. This means it could lead to earlier detection with less discomfort for patients. Additionally, it might provide faster results, helping doctors make quicker decisions about patient care.

What evidence suggests that this novel multiplex ELISA assay is effective for detecting BCa?

Research has shown that multiplex ELISA tests can detect several proteins simultaneously, making them more efficient than tests targeting a single protein. These tests have proven very accurate in predicting outcomes for various health conditions. For example, one study found that a multiplex test predicted survival with 83% accuracy. This technology also effectively identifies multiple infections at once, such as COVID-19 and the flu. This suggests that using a multiplex ELISA to detect bladder cancer markers in urine could be a promising and non-invasive method. ^{1 2 6 7 8}

Who Is on the Research Team?

Hideki Furuya, PhD

Principal Investigator

Cedars-Sinai Medical Center

Charles Rosser, MD

Principal Investigator

Nonagen Bioscience Corporation

Are You a Good Fit for This Trial?

Inclusion Criteria

Have documented or reported microscopic hematuria within 3 month of study enrollment

Willing and able to give written informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Evaluation

Participants undergo a non-invasive multiplex ELISA assay to detect BCa-associated diagnostic signatures in voided urine samples

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after the diagnostic evaluation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• A Novel Multiplex ELISA Assay

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Charles Rosser

Lead Sponsor

Trials

3

Recruited

1,700+

University of Texas, Southwestern Medical Center at Dallas

Collaborator

Trials

18

Recruited

21,200+

Nara Prefecture Seiwa Medical Center

Collaborator

Trials

2

Recruited

1,400+

VA Long Beach Healthcare System

Collaborator

Trials

16

Recruited

4,500+

University of Hawaii Cancer Research Center

Collaborator

Trials

11

Recruited

2,100+

Fred Hutchinson Cancer Center

Collaborator

Trials

583

Recruited

1,341,000+

Hoag Memorial Hospital Presbyterian

Collaborator

Trials

37

Recruited

17,200+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Nara Medical University

Collaborator

Trials

12

Recruited

5,400+

Citations

1. boneandjoint.org.uk boneandjoint.org.uk/Article/10.1302/2046-3758.143.BJR-2024-0100.R1

Rapid multiplex micro-ELISA assay for simultaneous ... The aim of this study was to present a novel multiplex micro-ELISA (μ-ELISA) method for the rapid and simultaneous measurement of alpha-defensin, IL-6, and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6680274/

ELISA in the multiplex era: Potentials and pitfalls - PMC Multiplex immunoassays confer several advantages over widely adopted singleplex immunoassays including increased efficiency at a reduced expense, greater output ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2589537022002255

A multiplex protein panel assay for severity prediction and ... In the post-dexamethasone cohort, the assay predicted survival with an accuracy of 0.83 (108/130), and death with an accuracy of 0.76 (26/34) in the median 2.5 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11194474/

Evaluating the efficiency of ELISA, monoplex and multiplex ... Probe‐based RT‐PCR revealed that 39.3% of patients were positive for the Flu A virus. Multiplex rRT‐PCR detect the SARS‐CoV‐2, Flu A, and Flu B ...

5. academic.oup.com academic.oup.com/biomedgerontology/article/63/8/879/567391

ELISA and Multiplex Technologies for Cytokine Measurement ... This article reviews ELISA and the emerging multiplex technologies, compares the cost and effectiveness of recently developed multiplex arrays with traditional ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2472630322016855

Dynex: Multiplex ELISA Technology Conventional enzyme-linked immunosorbent assay (ELISA) is a gold standard for screening antibodies and testing for protein or antigen presence.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8373222/

A Novel Multiplexed Enzyme-Linked Immunosorbent Assay ... This ELISA gives simple and reproducible results for detection of anti-CMV UL144 IgG. It may assist in differentiating natural infection from CMV vaccines that ...

8. researchgate.net researchgate.net/publication/318655689_Validation_of_novel_multiplex_technologies

(PDF) Validation of novel multiplex technologies One interesting application is for therapy monitoring, such as safety data, pharmacodynamics, evidences for mode-of-action and side effects, ...