Urinalysis Screening for Bladder Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Texas Southwestern Medical Center
Disqualifiers: Bladder cancer, Kidney cancer, Prostate cancer, others
No Placebo Group
Approved in 1 Jurisdiction
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.12345
Is urinalysis screening for bladder cancer safe for humans?
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.1011121314
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.
Trial 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 (Diagnostic Test)
Trial OverviewThe 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
2Treatment groups
Experimental Treatment
Active Control
Group I: BCa Early Screening GroupExperimental Treatment1 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 GroupActive Control1 Intervention
This will include historical control (bladder cancer detected in patients by standard of care) using SEER registries).
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Texas Southwestern Medical CenterDallas, TX
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Who Is Running the Clinical Trial?
University of Texas Southwestern Medical CenterLead Sponsor
References
Urinary cytology as a test in mass screening. [2019]A rapid and simple cytologic screening system for urinary tract cancer stained with toluidine blue was described. Utilizing this system, a hospital population was screened for urinary tract cancer from specimens sent for routine urinalysis. In this study of 16,062 fresh urine sediments selected at random from non-urologic patients, three cases histologically proven bladder cancer were detected, leading to the detection rate of one bladder cancer in 5,000 individuals. The results emphasizes the usefulness of this simple screening technique in combination with clinical urinalysis and cytology for early detection of urinary tract malignancy.
The fate of an unsatisfactory urine cytology test among patients with urothelial carcinoma. [2019]To determine the outcome of patients with a urinary cytology test that is unsatisfactory (UUCyt) for evaluation (
Results of Bard BTA test in monitoring patients with a history of transitional cell cancer of the bladder. [2010]To evaluate the sensitivity and specificity of the Bard BTA test compared with bladder washing cytology in patients with a history of transitional cell bladder cancer undergoing routine follow-up cystoscopy.
Diagnosis and empiric therapy of urinary tract infection in the seriously ill patient. [2019]Urinary tract infections (UTIs) are the most prevalent serious infections encountered by the typical physician. When these infections are an imminent threat, microscopic urinalysis rapidly provides sensitive and specific diagnostic information that can establish the diagnosis and guide initial therapy. Tests of localization of infection play no important role in early management decisions. The choice of empiric antibiotic therapy depends on the patterns of resistance in the patient's environment. Even when UTIs are nominally community acquired, an important minority of isolates are resistant to first-generation cephalosporins. Thus far the great majority of gram-negative urinary tract isolates have been susceptible to aminoglycosides and to third-generation cephalosporins. Appropriate therapy should promptly eradicate microscopically visible bacteriuria. Failure to do so after a day is presumptive evidence that the antibiotic is ineffective in vivo and is reason to change the antibiotic if the clinical condition warrants this. Conversely, the patient who fails to respond clinically despite eradication of microscopic bacteriuria is unlikely to fare better with a different antibiotic. In this setting, search for an isolated infected focus, such as an abscess, or for sites of dissemination of the infection is more likely to yield a solution.
A randomized controlled trial of a diagnostic algorithm for symptoms of uncomplicated cystitis at an out-of-hours service. [2022]To compare the clinical outcome of patients presenting with symptoms of uncomplicated cystitis who were seen by a doctor, with patients who were given treatment following a diagnostic algorithm.
Newly diagnosed bladder cancer: the relationship of initial symptoms, degree of microhematuria and tumor marker status. [2023]We recorded initial symptoms and evaluated the frequency and intensity of hematuria in patients with newly diagnosed bladder cancer. We also evaluated and compared the sensitivity of bladder wash cytology, NMP22 (Matritech, Newton, Massachusetts), BTA Stat (Bion Diagnostic Sciences, Redmond, Washington) and UBC antigen (IDL Biotech, Sollentona, Sweden) with hematuria dipsticks and flow cytometry for determining the size of erythrocytes in urine.
Diagnostic value of a urine-based tumor marker for screening lower urinary tract in low-risk patients with asymptomatic microscopic hematuria. [2022]To evaluate the use of NMP22 BladderChek® (NMP22BC) as an initial test in comparison to voided urine cytology for screening subjects with asymptomatic microscopic hematuria (AMH); those who are
Bladder cancer screening at the Dupont Chambers Works: a new initiative. [2019]Persons occupationally exposed to known or suspected human bladder carcinogens are being recruited for a 3-year case-control study of the efficacy of and adherence to a home self-testing protocol for microscopic hematuria as a method for early detection of treatable urologic conditions, including bladder cancer. All employees of the DuPont Chambers Works who are currently in the tumor surveillance program (those known to have been exposed to beta-naphthylamine, benzidine, and 4,4'-methylenebis(2-chloroaniline] will be asked to participate. Age-matched controls will be recruited from the community. Recent advances in identifying clinical signs of underlying bladder disease among the asymptomatic have been implemented in our screening design. Quarterly urinalyses will include the traditional microscopic examination of the urine to detect red blood cells. Participants will test their urine for microhematuria using the Ames HemastixR for 14 consecutive days every other quarter. On alternating quarters, cytologies will be performed. Persons who test positive (hematuria and/or abnormal cytology) will be referred for a complete urologic workup.
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]BTA stat®, NMP22® BladderChek®, UBC® Rapid Test, and CancerCheck® UBC® rapid VISUAL are urinary-based rapid tests. This multicenter study is the first study comparing all available rapid tests on a large cohort of bladder cancer patients and healthy controls in one setting.
Comparison of the clinical usefulness of different urinary tests for the initial detection of bladder cancer: a systematic review. [2022]The standard initial approach in patients with hematuria or other symptoms suggestive of bladder cancer (BC) is a combination of cystoscopy and urine cytology (UC); however, UC has low sensitivity particularly in low-grade tumors. The aim of the present review was to critically analyze and compare results in the literature of promising molecular urinary tests for the initial diagnosis of BC.
Urinary beta-glucuronidase activity as an initial screening test for urinary tract malignancy in high risk patients. Comparison with conventional urine cytologic evaluation. [2019]Routine urine cytology is not particularly useful as a screening test for urinary tract malignancy in the general population, due to its low detection rate. Bladder, ureteral, and pelvic lavage and flow cytometry increased the test sensitivity but could be applied only to a limited number of patients. A simple, sensitive screening test is needed.
Dipstick Urinalysis as a Test for Microhematuria and Occult Bladder Cancer. [2022]Introduction: There is a lack of evidence supporting the routine use of laboratory tests to detect bladder cancer. Identifying a cost-effective and widely available diagnostic aid may improve bladder cancer outcomes. We sought to evaluate the utility of dipstick urinalysis to detect microhematuria and diagnose bladder cancer in a large, diverse, contemporary cohort. Methods: All non-pregnant women and men 35 and older with a new diagnosis of microhematuria (≥3 RBC/hpf) were identified via a multi-center electronic medical record data warehouse query. Negative controls with no history of hematuria were randomly chosen and included to complete our cohort. Comparison between dipstick urinalysis and microscopic urinalysis on self-matched patients for the detection of microhematuria and diagnosis of bladder cancer was performed via Spearman's rank correlation coefficient, sensitivity/specificity testing, and ROC curve analysis. Results: A total of 46,842 patients were included. Spearman's rank order correlation (rho = 0.66) between degree of microhematuria on dipstick urinalysis and microscopic urinalysis indicated a strong positive relationship. The ROC curve for dipstick urinalysis to identify microhematuria had an AUC of 0.80 (95% CI 0.79-0.81). No difference (p = 0.83) in diagnostic accuracy between dipstick urinalysis (AUC 0.74, 95% CI 0.70-0.78) and microscopic urinalysis (AUC 0.73, 95% CI 0.69-0.78) as a test for bladder cancer was found. Conclusion: Dipstick urinalysis provides a highly specific test for microhematuria and similar accuracy to microscopic urinalysis when used as a diagnostic tool to detect bladder cancer.
Hematuria screening for bladder cancer. [2019]Detection of bladder cancer before deep invasion occurs offers patients a favorable prognosis. Because most bladder cancers, even when noninvasive, produce hematuria, screening asymptomatic persons at risk for bladder cancer for hematuria provides a means of promoting early detection and has the potential to reduce morbidity and mortality. However, bladder cancer-induced hematuria is quite intermittent; thus, repetitive testing is necessary. In a pilot study, 11.4% of asymptomatic men over age 50 who had at least one positive dipstick result were found on urologic work-up to have bladder cancers that were caught early enough to receive purportedly curative treatment. Issues concerning the applicability of this methodology to other high-risk populations are discussed and efforts now underway to confirm and expand upon this screening program are described.
A Quest for Accuracy: Evaluation of The Paris System in Diagnosis of Urothelial Carcinomas. [2023]Urine cytology is an important screening tool of patients for urothelial carcinoma (UC) and follow-up of patients with treated disease. Ease of procurement, cost-effectiveness, and lower turnaround time are the major advantages.