Urinalysis Screening for Bladder Cancer

Overseen By Yair Lotan, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Bladder cancer, Kidney cancer, Prostate cancer, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if regular urine tests (urinalysis) can detect bladder cancer early in high-risk individuals. Participants will undergo a simple urine test every six months for two years. If tests reveal any abnormalities, further checks such as imaging or specialized urine tests will follow. The trial seeks individuals aged 50 and older who have smoked heavily or worked in specific jobs, like textile or painting, for at least 15 years. As an unphased trial, this study provides an opportunity to contribute to important research that could lead to earlier detection of bladder cancer.

Will I have to stop taking my current medications?

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

What prior data suggests that urinalysis is safe for bladder cancer screening?

Research has shown that urinalysis is a safe and well-tolerated method for checking health issues. Used for thousands of years, it detects various conditions by examining a urine sample for signs of problems like urinary tract infections or kidney disease. For bladder cancer, urinalysis offers a non-invasive and affordable way to identify potential issues early.

Urinalysis itself poses no major safety concerns and is commonly performed in doctor's offices. However, the test may sometimes fail to detect cancer even if present, resulting in a false-negative result. Despite this limitation, the safety of urinalysis is well-established, making it a reliable choice for regular health check-ups. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it could revolutionize how we screen for bladder cancer. Unlike the standard methods that typically rely on invasive procedures like cystoscopy, this approach uses urinalysis, which is less invasive and can be performed more frequently. By analyzing urine samples every six months, doctors can potentially detect cancer earlier and with less discomfort for patients. This method could lead to earlier interventions and better outcomes compared to the traditional reliance on more invasive screenings.

What evidence suggests that urinalysis is effective for early detection of bladder cancer?

Research has shown that urine tests can help detect bladder cancer. One study found that a special urine test correctly identified bladder cancer in 66% of participants, even years before symptoms appeared. This trial will evaluate the effectiveness of regular urinalysis screening for early detection of bladder cancer. Participants in the BCa Early Screening Group will undergo urinalysis testing every six months for two years. Using specific markers in urine can accurately diagnose bladder cancer. These findings suggest that regular urine tests could detect bladder cancer earlier, potentially leading to better outcomes for high-risk individuals. ^{6 7 8 9 10}

Who Is on the Research Team?

Yair Lotan, MD

Principal Investigator

UT Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals aged 50 or older with a history of significant smoking (at least 15 pack-years) or those who've worked for over 15 years in certain jobs like textile work, painting, or dry cleaning. It's not open to people who've had bladder, kidney, or prostate cancer before, have been checked for blood in their urine recently, or won't give informed consent.

Inclusion Criteria

I am 50 years old or older.

You have smoked at least 15 packs of cigarettes per year.

I have worked for 15+ years in textiles, painting, or dry cleaning.

Exclusion Criteria

Do not provide informed consent

I have had bladder, kidney, or prostate cancer in the past.

You have had a test for blood in your urine (micro or gross hematuria) in the past 2 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Screening

Participants undergo urinalysis testing every 6 months for 2 years to assess for microhematuria and urine-based molecular markers

2 years

Bi-annual visits

Follow-up

Participants are monitored for outcomes and compared to historical controls

3 years

What Are the Treatments Tested in This Trial?

Interventions

• Urinalysis

Trial Overview The study is testing if doing a urine test every six months for two years can help detect bladder cancer early in people at high risk. There's no current standard screening process for this type of cancer.

How Is the Trial Designed?

Group I: BCa Early Screening Group Experimental Treatment 1 Intervention

All participants undergo Urinalysis testing every 6 months for 2 years. Based on the RBC count, each participant will go through each of the screening procedures : \[cystoscopy + Upper tract imaging\] or \[urine marker cancer testing with Cxbladder triage + Upper tract imaging\] or \[Repeat urinalysis\] Patients with suspicious findings on cystoscopy or imaging will get treatment as per standard of care. Their outcomes will be compared to a historical control (bladder cancer detected by standard of care using SEER registries).

Group II: Historical Control Group Active Control 1 Intervention

This will include historical control (bladder cancer detected in patients by standard of care) using SEER registries).

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Wilson Charitable Foundation Trust

Collaborator

Pacific Edge Limited

Industry Sponsor

Trials

8

Recruited

4,800+

Published Research Related to This Trial

In a study of 92 patients with newly diagnosed bladder cancer, the sensitivity of various diagnostic tests showed that NMP22 and BTA Stat were the most effective, with sensitivities of 75% and 78% respectively, while bladder wash cytology had a much lower sensitivity of 42%.

Despite 75% of patients presenting with microhematuria before surgery, the presence of macroscopic hematuria did not correlate with tumor characteristics, suggesting that while hematuria is common, it may not be a reliable indicator of tumor severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Newly diagnosed bladder cancer: the relationship of initial symptoms, degree of microhematuria and tumor marker status. Boman, H., Hedelin, H., Jacobsson, S., et al.[2023]

Microscopic urinalysis is a crucial tool for quickly diagnosing urinary tract infections (UTIs) and guiding initial antibiotic therapy, as it provides sensitive and specific information about the infection.

Most gram-negative bacteria causing UTIs remain susceptible to aminoglycosides and third-generation cephalosporins, but a significant number of community-acquired infections show resistance to first-generation cephalosporins, highlighting the importance of tailoring antibiotic choices based on local resistance patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnosis and empiric therapy of urinary tract infection in the seriously ill patient. Platt, R.[2019]

A randomized controlled trial involving 441 women with uncomplicated cystitis showed that treatment based on a diagnostic algorithm resulted in similar symptom resolution times (median of 3 days) compared to traditional doctor consultations.

The use of a diagnostic algorithm for treating uncomplicated cystitis is safe and effective, allowing for better use of consultation time and adherence to antibiotic guidelines, with no severe complications reported during the follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of a diagnostic algorithm for symptoms of uncomplicated cystitis at an out-of-hours service. Bollestad, M., Grude, N., Lindbaek, M.[2022]

This 3-year case-control study aims to evaluate the effectiveness and adherence to a home self-testing protocol for detecting microscopic hematuria, which could indicate treatable urologic conditions like bladder cancer, among workers exposed to known carcinogens.

Participants will conduct urine tests every other quarter, and those with positive results will receive further urologic evaluations, enhancing early detection strategies for bladder disease in at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bladder cancer screening at the Dupont Chambers Works: a new initiative. Mason, TJ., Vogler, WJ.[2019]

A new cytologic screening method using toluidine blue was tested on 16,062 urine samples from non-urologic patients, successfully identifying three cases of bladder cancer.

This screening technique demonstrated a detection rate of one bladder cancer for every 5,000 individuals, highlighting its potential for early detection of urinary tract cancers when used alongside routine urinalysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urinary cytology as a test in mass screening. Nemoto, R., Kato, T., Shibata, K., et al.[2019]

In a study of 164 patients under 40 years old with asymptomatic microscopic hematuria, the NMP22 BladderChek® test showed higher sensitivity and predictive values compared to voided urine cytology, making it a more effective initial screening tool.

The study suggests that for low-risk patients, using non-invasive methods like upper tract imaging followed by the NMP22BC test is preferable to traditional urine cytology for bladder cancer screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic value of a urine-based tumor marker for screening lower urinary tract in low-risk patients with asymptomatic microscopic hematuria. Sagnak, L., Ersoy, H., Gucuk, O., et al.[2022]

In a study analyzing 732 urine samples from bladder cancer patients and healthy controls, the BTA stat® and UBC® Rapid Test showed the highest sensitivity for detecting high-grade non-muscle-invasive bladder cancer, making them valuable tools for diagnosis.

While BTA stat® and UBC® Rapid Test excelled in sensitivity, the NMP22® BladderChek® and cytology tests demonstrated higher specificity, indicating that a combination of these tests could enhance diagnostic accuracy in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BTA stat®, NMP22® BladderChek®, UBC® Rapid Test, and CancerCheck® UBC® rapid VISUAL as urinary marker for bladder cancer: Final results of a German multicenter study. Ecke, TH., Meisl, CJ., Schlomm, T., et al.[2023]

ImmunoCyt demonstrated the highest sensitivity for detecting bladder cancer compared to traditional urine cytology, especially in low-grade tumors, indicating it may be a more effective initial diagnostic tool.

While many molecular urinary tests showed improved sensitivity over urine cytology, none have yet been accepted into international guidelines for bladder cancer diagnosis due to variability in study results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the clinical usefulness of different urinary tests for the initial detection of bladder cancer: a systematic review. Sciarra, A., Di Lascio, G., Del Giudice, F., et al.[2022]

A study involving 146 patients found that measuring urinary beta-glucuronidase activity is significantly more sensitive for detecting urinary tract malignancies than routine urine cytology, with sensitivities of 94% for transitional cell carcinoma and 98% for renal cell carcinoma.

The accuracy of the beta-glucuronidase test was over 98%, compared to much lower sensitivities of urine cytology (41% for transitional cell carcinoma and 0% for renal cell carcinoma), highlighting its potential as a better screening tool for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urinary beta-glucuronidase activity as an initial screening test for urinary tract malignancy in high risk patients. Comparison with conventional urine cytologic evaluation. Ho, KJ., Kuo, SH.[2019]

In a study of 46,842 patients, dipstick urinalysis demonstrated a strong correlation with microscopic urinalysis for detecting microhematuria, indicating it can effectively identify potential bladder cancer cases.

The diagnostic accuracy of dipstick urinalysis for bladder cancer was found to be similar to that of microscopic urinalysis, suggesting it could be a cost-effective and accessible alternative for screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dipstick Urinalysis as a Test for Microhematuria and Occult Bladder Cancer. Matulewicz, RS., DeLancey, JO., Pavey, E., et al.[2022]

In a pilot study, 11.4% of asymptomatic men over 50 with positive dipstick tests for hematuria were found to have early-stage bladder cancer, highlighting the potential for early detection through screening.

Screening for hematuria in high-risk populations could significantly improve bladder cancer prognosis by allowing for earlier, potentially curative treatment, although further research is needed to validate this approach in broader groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hematuria screening for bladder cancer. Messing, EM., Vaillancourt, A.[2019]

The study of 90 cases showed that using The Paris System (TPS) for urine cytology reporting improved the sensitivity (83.3%) and accuracy (86.52%) in detecting high-grade urothelial carcinoma (HGUC) compared to the current system of reporting (CSR).

TPS also reduced the reporting of atypical urothelial cells (AUC) to 11.1%, which is lower than the 16.7% reported with CSR, and provided a better positive predictive value (100%) for HGUC diagnosis, indicating it enhances diagnostic reliability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Quest for Accuracy: Evaluation of The Paris System in Diagnosis of Urothelial Carcinomas. Rai, S., Lali, BS., Venkataramana, CG., et al.[2023]

The Bard BTA test demonstrated higher sensitivity (54%) compared to bladder washing cytology (23%) in detecting transitional cell bladder cancer during routine follow-up in 75 patients, indicating it may be more effective in identifying potential tumors.

While the Bard BTA test is more sensitive, it has lower specificity, with 9% of tests yielding clinically unconfirmed positive results, suggesting it should be used alongside cystoscopy and cytology for better overall surveillance of bladder cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of Bard BTA test in monitoring patients with a history of transitional cell cancer of the bladder. Ianari, A., Sternberg, CN., Rossetti, A., et al.[2010]

In a study of 142 patients with unsatisfactory urinary cytology tests (UUCyt), 33.9% were found to have urothelial carcinoma, indicating that UUCyt results should not be considered negative for cancer.

Among the cases, 16.3% had bladder cancer at the time of the UUCyt, and 17.5% developed new or recurrent bladder cancer within a year, with a significant portion of these being high-grade tumors, highlighting the need for further investigation through cystoscopy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The fate of an unsatisfactory urine cytology test among patients with urothelial carcinoma. Ordon, M., Boerner, S., Zlotta, AR., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3627848/

Bladder Cancer Detection and Monitoring: Assessment of ... In this article, we assess the performance of current diagnostic assays for bladder cancer and discuss some of the emerging biomarkers that could be developed.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2483317/

Critical Evaluation of Urinary Markers for Bladder Cancer ... The accuracy of urine cytology in predicting bladder cancer recurrence may vary widely among institutions.

3. mdpi.com mdpi.com/2072-6694/17/8/1283

Novel Urinary Biomarkers for the Detection of Bladder ... This review considers the newest noninvasive methods of BCa detection using urine-based biomarkers that can diagnose the disease with high sensitivity.

4. emedicine.medscape.com emedicine.medscape.com/article/438262-workup

Bladder Cancer Workup Microscopic hematuria from bladder cancer may be intermittent; therefore, a repeat negative result on urinalysis does not exclude the diagnosis.

5. medicalnewstoday.com medicalnewstoday.com/articles/bladder-cancer-new-urine-test-detects-disease-years-before-symptoms

Bladder cancer: New test may help predict disease years ... The modified UroAmp test accurately predicted the development of bladder cancer in 66% of participants up to twelve years before participants ...

6. hopkinsmedicine.org hopkinsmedicine.org/health/conditions-and-diseases/bladder-cancer/bladder-cancer-screening-and-diagnosis

Bladder Cancer Screening and Diagnosis The most efficient, noninvasive and inexpensive test is a urinalysis/cytology. Here, a sample of urine is taken from the patient and evaluated for cancer ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK557685/

Urinalysis - StatPearls - NCBI Bookshelf - NIH Urinalysis was the first laboratory test developed in the history of medicine, how it has been persistently used for several thousand years,

8. cancer.gov cancer.gov/types/bladder/screening

Bladder Cancer Screening - NCI False-negative test results. Screening test results may appear to be normal even though bladder cancer is present.

9. mayoclinic.org mayoclinic.org/tests-procedures/urinalysis/about/pac-20384907

Urinalysis A urinalysis is a test of your urine. It's used to detect and manage a wide range of disorders, such as urinary tract infections, kidney disease and diabetes.

10. clinicaltrials.gov clinicaltrials.gov/study/NCT05646485?term=AREA%5BBasicSearch%5D(urinary%20bladder%20cancer%20AND%20registry)&rank=10

Study Details | NCT05646485 | Bladder Cancer Screening ... Bladder cancer is currently detected in 2-5% of patients who have microhematuria on routine urinalysis, a cheap, non-invasive test obtained by many primary care ...