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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am 50 years old or older.

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Bladder cancer (BCa)

Secondary outcome measures

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

Screening interval

Smoking cessation

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,048 Previous Clinical Trials

1,052,811 Total Patients Enrolled

Yair Lotan, MDPrincipal InvestigatorUT Southwestern Medical Center

8 Previous Clinical Trials

2,231 Total Patients Enrolled

Media Library

Urinalysis Clinical Trial Eligibility Overview. Trial Name: NCT05646485 — N/A

Blood in Urine Research Study Groups: BCa Early Screening Group, Historical Control Group

Blood in Urine Clinical Trial 2023: Urinalysis Highlights & Side Effects. Trial Name: NCT05646485 — N/A

Urinalysis 2023 Treatment Timeline for Medical Study. Trial Name: NCT05646485 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are actively enrolled in this clinical trial?

"That is correct. According to the listings on clinicaltrials.gov, this medical experiment was first made available on May 5th 2023, and is currently recruiting volunteers for participation. A total of 1000 test subjects are required from a single site."

Answered by AI

Is there currently an opportunity to join this research endeavor?

"As per clinicaltrials.gov, this research project is still enrolling volunteers. The initial posting date was May 5th 2023 and it has since been modified on the 6th of that same month."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Bladder Cancer Screening Trial

yair lotan 2023. "Bladder Cancer Screening Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05646485.