Health TrialsbyHealthPanel

Bladder Cancer Screening Trial

ConditionsBladder CancerUrothelial CarcinomaHematuriaSmoking Cessation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorUniversity of Texas Southwestern Medical Center

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 50

Smoking: ≥15 pack-year smoking history

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

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • Urinalysis

    Diagnostic 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 - \[cystoscopy + Upper tract imaging\].

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: BCa Early Screening GroupExperimental treatment 1 intervention
Group B: Historical Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Incidence of Bladder cancer (BCa)

Incidence of Bladder cancer is measured by the number of participants who were detected with BCa.

Time frame
5 years

Secondary outcomes

1

Smoking cessation

Smoking cessation is measured by number of participants who were referred to smoking cessation treatment

Time frame
3 years
2

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

Time frame
approx. every 6 months for up to 2 years
3

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

Time frame
approx. every 12 months for up to 2 years
4

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

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Texas Southwestern Medical Center

Lead sponsor

Wilson Charitable Foundation Trust

Collaborator

Pacific Edge Limited

Collaborator

Source ClinicalTrials.gov
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