Diagnostic Tool for Bladder Cancer

Recruiting at 1 trial location

Overseen By Charles J Rosser

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Bladder cancer, Hematuria, Urinary infection, others

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

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance early detection of bladder cancer through a special urine test, the Bladder Cancer Diagnostic Test. The goal is to increase the test's reliability in identifying bladder cancer signs without invasive procedures. Suitable candidates include individuals over 50 with a history of heavy smoking and no history of bladder cancer. Participants must visit a clinic every six months for four years to provide urine samples for testing. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could lead to earlier and less invasive bladder cancer detection.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this diagnostic test is safe?

Research has shown that the bladder cancer test under study is safe and painless. It uses urine samples to detect bladder cancer, avoiding surgery or other invasive methods.

Tests such as the UroVysion Bladder Cancer Kit have received FDA approval, confirming they meet safety standards. These tests identify chromosomal changes that might indicate cancer.

Overall, these diagnostic tests are easy for patients to manage and have no reports of serious side effects. The primary goal is to detect cancer early using methods that are safe and simple for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this new bladder cancer diagnostic test because it aims to detect the disease much earlier than current methods like cystoscopy and urine cytology. Unlike standard procedures, which can be invasive or sometimes miss early-stage cancer, this test could offer a non-invasive and potentially more accurate detection method. Earlier detection means treatment can begin sooner, which could improve outcomes and reduce the need for more aggressive treatments later on.

What evidence suggests that this bladder cancer diagnostic test is effective for detecting bladder cancer?

Research has shown that the Oncuria-Detect bladder cancer test yields promising results. In one study, this test correctly identified bladder cancer in 62 out of 73 cases, achieving an accuracy of 85% in detecting the disease. Another test, the urinary PENK methylation test, demonstrated even greater accuracy, identifying bladder cancer 87.5% of the time and correctly ruling out the disease in 95.8% of cases. These findings suggest that these tests can effectively detect bladder cancer, providing a reliable and non-invasive method for early diagnosis. ^{6 7 8 9 10}

Who Is on the Research Team?

Hideki Furuya

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

Inclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Testing

Participants undergo urine-based diagnostic testing to identify bladder cancer

5 years

Follow-up

Participants are monitored for the development of bladder cancer and the performance of the diagnostic test

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Bladder Cancer Diagnostic Test

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

VA Long Beach Healthcare System

Collaborator

Trials

16

Recruited

4,500+

Nonagen Bioscience Corporation

Industry Sponsor

Trials

5

Recruited

2,300+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2950393025000828?via%3Dihub

Bladder cancer prevalence and diagnostic test accuracy For CT urography for bladder cancer (Table 4, Table 5), the sensitivity was 58.6% (95% CI 40.7–76.6) and the specificity was 97.7% (95% CI 95.1–100). Table 3.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40714361/

Bladder cancer prevalence and diagnostic test accuracy The overall prevalence of bladder cancer was 18% (95% CI 13.4 - 22.7). Regarding diagnostic performance, sensitivities were estimated at 70.6% ( ...

3. translational-medicine.biomedcentral.com translational-medicine.biomedcentral.com/articles/10.1186/s12967-025-06749-z

Performance of the Oncuria-Detect bladder cancer test for ... In the test set, the Oncuria-Detect assay correctly identified bladder cancer in 62 of 73 cases resulting in a sensitivity of 85%, a ...

4. uspreventiveservicestaskforce.org uspreventiveservicestaskforce.org/home/getfilebytoken/L5UwXoftg4JHw4buVDhjUT

Screening Adults for Bladder Cancer In terms of indirect evidence, we could not estimate the effectiveness of treatments for screen-detected bladder cancer because no studies compared clinical ...

5. nature.com nature.com/articles/s41598-025-07173-5

Diagnostic accuracy of urinary PENK methylation test for ... The urinary PENK methylation test showed an overall sensitivity of 94.1% (87.5% for bladder cancer and 100% for UTUC) and a specificity of 95.8% ...

6. cepheid.com cepheid.com/en-GB/tests/oncology-human-genetics/xpert-bladder-cancer-detection.html

Xpert® Bladder Cancer Detection Five mRNA biomarkers were intensively validated for the detection of bladder cancer · The non-invasive and painless test uses voided urine samples · The test is ...

7. molecular.abbott molecular.abbott/us/en/products/oncology/urovysion-bladder-cancer-kit

UroVysion Bladder Cancer Kit The UroVysion Bladder Cancer Kit (UroVysion Kit) is FDA approved and designed to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus.

8. globalpointofcare.abbott globalpointofcare.abbott/us/en/product-details/nmp22-bladderchek.html

NMP22 BladderChek 99% sensitivity when combined with cystoscopy, giving greater confidence that recurrent cancer has been detected. · 99% NPV overall when combined with cystoscopy ...

9. cepheid.com cepheid.com/en-CY/tests/oncology-human-genetics/expert-bladder-cancer-monitor.html

Xpert® Bladder Cancer Monitor Xpert Bladder Cancer Monitor is a non-invasive biomarker test with proven clinical sensitivity and specificity for low and high-grade bladder cancer. The ...

10. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK536923/

Bladder Cancer - StatPearls - NCBI Bookshelf Cystoscopy has been reported to demonstrate a sensitivity of 92% and specificity of 88% for MIBC, along with a positive predictive value of 72% to 78% and a ...