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

Trial Summary

What is the purpose of this trial?

There is currently no accepted screening strategy for patients at high risk of developing bladder cancer. This study will ask patients to complete a urine test every 6 months for 2 years to help assess if routine screening helps finding bladder cancer at an earlier stage.

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 data supports the effectiveness of the treatment Urinalysis Screening for Bladder Cancer?

Research shows that combining urinalysis with cytology (study of cells) can help in early detection of bladder cancer, as seen in a study where this method detected bladder cancer in one out of 5,000 individuals. This suggests that urinalysis can be a useful tool in screening for bladder cancer. ^{1 2 3 4 5}

Is urinalysis screening for bladder cancer safe for humans?

Urinalysis, which involves examining urine for signs of disease, is generally safe for humans. It is a non-invasive test commonly used to detect various conditions, including bladder cancer, and does not pose significant risks to participants. ^{1 6 7 8 9}

How does urinalysis differ from other treatments for bladder cancer?

Urinalysis is a non-invasive, cost-effective screening tool that detects bladder cancer by identifying blood in the urine (hematuria), which is often an early sign of the disease. Unlike more invasive procedures like cystoscopy, urinalysis can be easily repeated and is accessible for early detection, especially in high-risk individuals. ^{10 11 12 13 14}

Research Team

Yair Lotan, MD

Principal Investigator

UT Southwestern Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

References

1. Japan pubmed.ncbi.nlm.nih.gov

Urinary cytology as a test in mass screening. [2019]

2. England pubmed.ncbi.nlm.nih.gov

The fate of an unsatisfactory urine cytology test among patients with urothelial carcinoma. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Results of Bard BTA test in monitoring patients with a history of transitional cell cancer of the bladder. [2010]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of a diagnostic algorithm for symptoms of uncomplicated cystitis at an out-of-hours service. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Newly diagnosed bladder cancer: the relationship of initial symptoms, degree of microhematuria and tumor marker status. [2023]

7. Switzerland 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Bladder cancer screening at the Dupont Chambers Works: a new initiative. [2019]

9. United States 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. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Comparison of the clinical usefulness of different urinary tests for the initial detection of bladder cancer: a systematic review. [2022]

11. United States 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. [2019]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Dipstick Urinalysis as a Test for Microhematuria and Occult Bladder Cancer. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Hematuria screening for bladder cancer. [2019]

14. India pubmed.ncbi.nlm.nih.gov

A Quest for Accuracy: Evaluation of The Paris System in Diagnosis of Urothelial Carcinomas. [2023]