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Urinalysis Screening for Bladder Cancer

N/A

Recruiting

Led By Yair Lotan, MD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 50

Occupation:≥ 15 years of occupational exposures including: textile worker, painter, dry cleaners

Must not have

Prior history of bladder, kidney, or prostate cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will investigate if routine urine tests can help detect bladder cancer earlier in high-risk patients.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the intervention involves only routine urinalysis tests and does not include medication or invasive procedures, there are generally no direct side effects associated with participating in this clinical trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 50 years old or older.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Bladder cancer (BCa)

Secondary study objectives

Number of participants with positive/ negative markers and findings on cystoscopy

Screening interval

Smoking cessation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Urinalysis

2019

Completed Phase 1

~70

0 / 3Eligibility criteria met