A Diagnostic for the Early Detection of Bladder Cancer

  • STATUS
    Recruiting
  • End date
    Dec 30, 2026
  • participants needed
    150
  • sponsor
    Cedars-Sinai Medical Center
Updated on 16 May 2022
bladder tumor
Accepts healthy volunteers

Summary

To improve upon the non-invasive detection of bladder cancer by further validating a multiplex ELISA assay directed at a bladder cancer-associated diagnostic signature in voided urine samples of patients with a high risk of developing bladder cancer.

Description

Environmental exposures, specifically tobacco smoke, increases the risk of many cancers, including bladder cancer. To date, there are no diagnostics capable of detecting bladder cancer early, that is prior to clinical presentation. Because of this severe limitation, nearly 30% of patients initially present with stage 2 and higher bladder cancer. Stage 2 bladder cancer has a 5-year survival of 50%, while stage 3/4 have a 5-year survival of <20%. Ideally, bladder cancer would be preventable. Unfortunate, this has not come to fruition. If these stage 2-4 bladder cancer cases could be detected at Stage 1 (5-yr survival >94%), then its possible to see an improvement in bladder cancer survival rates (21-23).

in this study, a urine-based diagnostic that possesses the potential to accurately identify patients who harbor bladder cancer prior to clinical manifestation will be tested.

Details
Condition Bladder Cancer
Clinical Study IdentifierNCT05347342
SponsorCedars-Sinai Medical Center
Last Modified on16 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants must be
Age 50 years or older
Males
>30 pack year history of tobacco exposure
Free of any malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years. Patients with localized prostate cancer who are being followed by an active surveillance program are also eligible
Scheduled to be evaluated in the Pulmonary Rehab Clinic or Lung Cancer Screening Clinic
Willing and able to give written informed consent
Willing to provide voided urine sample
Be able and willing to complete semi-annual research clinic visits for 4 years

Exclusion Criteria

Participants must not have
History of hematuria (microscopic or gross) within 2 years of signing consent
Previous history of bladder cancer
A known active urinary tract infection or urinary retention
An active stone disease (renal or bladder) or renal insufficiency (creatinine >2.0 mg/dL) - Serum creatinine value can be up to 2 years before consent, otherwise repeat
An ureteral stents, nephrostomy tubes or bowel interposition
A recent genitourinary instrumentation (within 7 days prior to collection of voided urine sample)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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