Assay Utility for the Diagnosis of Bladder Cancer in Patients with Atypical Cytology or Equivocal Cystoscopy

Overview

About this study

The primary objective of the study is to evaluate the performance characteristics (sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV)) of the Bladder CARE™ Assay compared to atypical cytology or equivocal cystoscopy results for detecting bladder cancer.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Patients 18 years of age at time of informed consent.
  • Subject or the subject’s legally authorized representative provides written informed consent.
  • Subject is willing to follow all study procedures and available for the duration of the study.
  • Patients with atypical cytology or equivocal cystoscopy results within 3 months before screening.
  • Subject is scheduled for initial or repeat cystoscopy, with or without pathology.
  • Subject is willing to provide one voided urine specimen of at least 80 ml on the same day, but prior to scheduled initial or repeat cystoscopy, with or without pathology.

Exclusion Criteria:

  • Pregnant or planning to become pregnant at the time of screening.
  • Positive cystoscopy within 3 months of screening indicating presence of bladder cancer.
  • Genitourinary manipulation (flexible or rigid cystoscopy, catheterization, urethral dilation, URS, ureteral stent) within 14 days before urine specimen collection.
  • History of augmentation cystoplasty.
  • History of continent cutaneous diversion or ileal conduit.
  • History of orthotopic bladder substitution or orthotopic neobladder.
  • Concomitant use of an investigational drug which has been administered or may be administered within the 30 days leading up to providing informed consent or may be administered through the time of urine specimen.
  • Active cancer diagnosis or prior cancer diagnosis within 3 months before enrollment.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Robert Karnes, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20583568

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