Bladder CancerNCT05646485
Bladder Cancer Screening Trial
A study testing Urinalysis in people with Bladder Cancer and Urothelial Carcinoma, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Bladder Cancer, Urothelial Carcinoma, Hematuria
- What is being tested?
- Urinalysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2023to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 50
- Smoking: ≥15 pack-year smoking history
- Occupation:≥ 15 years of occupational exposures including: textile worker, painter, dry cleaners
Who cannot join
- Prior history of bladder, kidney, or prostate cancer
- Prior evaluation of micro or gross hematuria within the last 2 years
- Do not provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Sonobia Garrett, 214-645-8787
Yair Lotan, MD
About this study
Official title: Optimal Screening Strategy for Bladder Cancer in at Risk Patients
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.
Read the detailed description
Bladder cancer is the 4th most common cancer in men and 6th most common cancer overall with over 80,000 new cases in the US per year. The most common causes of bladder cancer are smoking and it is usually found in patients over the age of 50. By the time it is diagnosed, the disease is often advanced since there are few warning signs other than seeing blood in the urine.
Screening is currently accepted practice for colon, cervical, and breast cancer. However, there is not an accepted screening methodology for bladder cancer. 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 physicians. Bladder cancer diagnosed by microscopic blood on urinalysis is often lower stage than patients diagnosed with visible blood. Urine testing, therefore, offers a simple screening mechanism that can be tailored to patients at higher risk for bladder cancer based on age, tobacco exposure and other risk factors. In conjunction with routine traditional urinalysis testing, there are advances in urine molecular markers which utilize protein and genetic alterations resulting in a higher sensitivity and specificity for the detection of bladder cancer. Markers have not been evaluated for screening in high-risk populations, and there is a gap in knowledge of the most accurate screening method.
Early detection of bladder cancer has the potential to identify disease at an earlier stage resulting in a lower burden of treatment, improved quality of life, and improved survival.
This study will prospectively screen patients at high risk for the development of bladder cancer at bi-annual intervals with a commonly available urinalysis test that assess for microhematuria and urine based molecular markers.
This is a single arm study. The outcomes from the experimental arm will be compared to a historical control (bladder cancer detected by standard of care using SEER registries).
- Conditions
- Bladder Cancer, Urothelial Carcinoma, Hematuria, Smoking Cessation
- Being tested
- Urinalysis
- Medical subject headings
- Urinary Bladder Neoplasms, Carcinoma, Transitional Cell, Hematuria, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UrinalysisDiagnostic test
Urine analysis (every 6 months for 2 years); Patients with <3 red blood cells (RBCs) per high-powered field (HPF) will repeat screening at 6-month intervals for an average of 2 years.
If RBCs are 3-25 RBSc/HPF- subjects will undergo- [cystoscopy + Upper tract imaging] or [urine marker cancer testing with Cxbladder triage + Upper tract imaging].
If >25 RBCs, subjects will get - [cystoscopy + Upper tract imaging].
| Study group | Role | What they receive |
|---|---|---|
| BCa Early Screening Group | Experimental | 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). Receives: Diagnostic Test: Urinalysis |
| Historical Control Group | No intervention | This will include historical control (bladder cancer detected in patients by standard of care) using SEER registries). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Bladder cancer (BCa)
Incidence of Bladder cancer is measured by the number of participants who were detected with BCa.
Measured: 5 years
Secondary outcomes (4)
Smoking cessation
Smoking cessation is measured by number of participants who were referred to smoking cessation treatment
Measured: 3 years
Screening interval
Screening interval is assessed by calculating the average screening interval from baseline until the timepoint when RBCs >3 are detected for each participant
Measured: approx. every 6 months for up to 2 years
Screening interval
Screening interval is assessed by calculating the average screening interval from baseline until the timepoint when RBCs >3 are detected for each participant
Measured: approx. every 12 months for up to 2 years
Number of participants with positive/ negative markers and findings on cystoscopy
Performance of urinalysis and molecular markers is assessed by the count of participants with positive/ negative markers and findings on cystoscopy
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start5 May 2023
- Primary completionApr 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Wilson Charitable Foundation Trust, Pacific Edge Limited
- Responsible party
- Principal investigator, yair lotan, University of Texas Southwestern Medical Center
- Investigators
- Yair Lotan, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646485
- Sponsor's protocol ID
- STU-2022-1042
- Status last verified
- Apr 2026
- First submitted
- 1 Dec 2022
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Screening Strategy for Bladder Cancer in at Risk Patients
- ClinicalTrials.gov ID
- NCT05646485
- Acronym / sponsor ID
- STU-2022-1042
- Conditions
- Bladder Cancer, Urothelial Carcinoma, Hematuria, Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Wilson Charitable Foundation Trust, Pacific Edge Limited
- Study start
- 5 May 2023 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Bladder cancer is the 4th most common cancer in men and 6th most common cancer overall with over 80,000 new cases in the US per year. The most common causes of bladder cancer are smoking and it is usually found in patients over the age of 50. By the time it is diagnosed, the disease is often advanced since there are few warning signs other than seeing blood in the urine.
Screening is currently accepted practice for colon, cervical, and breast cancer. However, there is not an accepted screening methodology for bladder cancer. 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 physicians. Bladder cancer diagnosed by microscopic blood on urinalysis is often lower stage than patients diagnosed with visible blood. Urine testing, therefore, offers a simple screening mechanism that can be tailored to patients at higher risk for bladder cancer based on age, tobacco exposure and other risk factors. In conjunction with routine traditional urinalysis testing, there are advances in urine molecular markers which utilize protein and genetic alterations resulting in a higher sensitivity and specificity for the detection of bladder cancer. Markers have not been evaluated for screening in high-risk populations, and there is a gap in knowledge of the most accurate screening method.
Early detection of bladder cancer has the potential to identify disease at an earlier stage resulting in a lower burden of treatment, improved quality of life, and improved survival.
This study will prospectively screen patients at high risk for the development of bladder cancer at bi-annual intervals with a commonly available urinalysis test that assess for microhematuria and urine based molecular markers.
This is a single arm study. The outcomes from the experimental arm will be compared to a historical control (bladder cancer detected by standard of care using SEER registries).
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BCa Early Screening Group | Experimental | Diagnostic Test: UrinalysisAll 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). |
| Historical Control Group | No intervention | –This will include historical control (bladder cancer detected in patients by standard of care) using SEER registries). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 50
- Smoking: ≥15 pack-year smoking history
- Occupation:≥ 15 years of occupational exposures including: textile worker, painter, dry cleaners
Key exclusion criteria (3 listed)
- Prior history of bladder, kidney, or prostate cancer
- Prior evaluation of micro or gross hematuria within the last 2 years
- Do not provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UrinalysisUrine analysis (every 6 months for 2 years); Patients with <3 red blood cells (RBCs) per high-powered field (HPF) will repeat screening at 6-month intervals for an average of 2 years. If RBCs are 3-25 RBSc/HPF- subjects will undergo- [cystoscopy + Upper tract imaging] or [urine marker cancer testing with Cxbladder triage + Upper tract imaging]. If >25 RBCs, subjects will get - [cystoscopy + Upper tract imaging]. | Diagnostic test | BCa Early Screening Group |
Primary outcome
Incidence of Bladder cancer (BCa)
Time frame: 5 years
Incidence of Bladder cancer is measured by the number of participants who were detected with BCa.
4 secondary outcomes
Smoking cessation
Time frame: 3 years
Screening interval
Time frame: approx. every 6 months for up to 2 years
Screening interval
Time frame: approx. every 12 months for up to 2 years
Number of participants with positive/ negative markers and findings on cystoscopy
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yair Lotan, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urinalysis in people with Bladder Cancer and Urothelial Carcinoma, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yair Lotan, MD (214-648-0389, yair.lotan@UTsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Bladder cancer (BCa) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.