Evaluating Bladder CARE™, a New Non-Invasive Urine Test, for Bladder Cancer Detection in Inconclusive Cases

January 2, 2026 updated by: Pangea Laboratory LLC

Prospective Evaluation of Bladder CARE™ Assay Utility for the Diagnosis of Bladder Cancer in Patients With Atypical Cytology or Equivocal Cystoscopy

The goal of this observational study is to learn about the performance of the Bladder CARE™ Assay in patients suspected of having bladder cancer with atypical cytology or equivocal cystoscopy results. The main question it aims to answer is:

• Does the Bladder CARE™ Assay detect bladder cancer in patients who have inconclusive cytology or cystoscopy results?

Participants will provide one voided urine specimen on the day of, and prior to, the routine, scheduled standard of care initial or repeat cystoscopy procedure. A medical records review will occur at two follow-up timepoints, (6 months and 12 months after the urine specimen collection), to document oncology-urinary-related clinical outcomes.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Urology practice

Description

Inclusion Criteria:

  1. Patients ≥ 18 years of age at time of informed consent.
  2. Subject or the subject's legally authorized representative provides written informed consent.
  3. Subject is willing to follow all study procedures and available for the duration of the study.
  4. Patients with atypical cytology or equivocal cystoscopy results within 3 months before screening.
  5. Subject is scheduled for initial or repeat cystoscopy, with or without pathology.
  6. 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:

  1. Pregnant or planning to become pregnant at the time of screening.
  2. Positive cystoscopy within 3 months of screening indicating presence of bladder cancer.
  3. Genitourinary manipulation (flexible or rigid cystoscopy, catheterization, urethral dilation, URS, ureteral stent) within 14 days before urine specimen collection.
  4. History of augmentation cystoplasty.
  5. History of continent cutaneous diversion or ileal conduit.
  6. History of orthotopic bladder substitution or orthotopic neobladder.
  7. 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.
  8. New or recurrent NMIBC (non-muscle invasive bladder cancer) diagnosis within three months of study enrollment.
  9. An active malignancy (bladder or other) diagnosis within 3 months of study enrollment.
  10. Patients with a history of NMIBC have undergone intravesical or infusion therapy and completed treatment less than 6 weeks prior to study enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate Bladder CARE™ Assay performance for detecting bladder cancer in patients with atypical cytology or equivocal cystoscopy
Time Frame: From enrollment to the end of the study at 12 months
Assess the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), of the Bladder CARE™ Assay to the gold standard diagnostic methods for detecting bladder cancer in patients with atypical cytology or equivocal cystoscopy results.
From enrollment to the end of the study at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pangea Laboratory LLC

Investigators

  • Principal Investigator: Jeffrey R. Karnes, M.D., Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

March 5, 2025

First Submitted That Met QC Criteria

March 5, 2025

First Posted (Actual)

March 11, 2025

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

January 2, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAN001-24 BCA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

This IPD sharing plan entails sharing de-identified individual participant data (IPD) exclusively through the publication of results from this clinical trial in a reputable medical journal. The shared data will include essential de-identified demographic information such as age, gender, race/ethnicity, clinical outcomes and summary results. Additionally, the performance metrics of the Bladder CARE™ Assay will be disclosed, providing insights into its effectiveness and utility in clinical settings.

By disseminating this information through a peer-reviewed journal, we aim to contribute to the scientific community's understanding of the Bladder CARE™ Assay and its implications for patient care, while ensuring that the data is contextualized within the scope of our research findings. This approach aligns with our commitment to transparency and the advancement of medical knowledge. Once accepted, the article will be published.

IPD Sharing Time Frame

Beginning 1 year after publication with no end date

IPD Sharing Access Criteria

Investigators whose proposed use of the data has been approved by an independent review committee and a signed data use agreement

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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