ACTIVE_NOT_RECRUITING

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

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Conditions

Bladder CancerUrothelial Carcinoma BladderBladder CARE™Atypical CytologyEquivocal CystoscopyBladder Cancer DetectionHematuriaNon-Invasive Urine TestUrologicalUrologyMicrohematuriaGross HematuriaUrothelial CarcinomaBladder Cancer BiomarkersUrinary BiomarkerUrologic OncologyInconclusive Cystoscopy ResultsInconclusive Cytology ResultsUrine-Based Bladder Cancer Detection

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-06-03
Study Completion:2027-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06870253

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.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients ≥ 18 years of age at time of informed consent.
  2. 2. Subject or the subject's legally authorized representative provides written informed consent.
  3. 3. Subject is willing to follow all study procedures and available for the duration of the study.
  4. 4. Patients with atypical cytology or equivocal cystoscopy results within 3 months before screening.
  5. 5. Subject is scheduled for initial or repeat cystoscopy, with or without pathology.
  6. 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.
  1. 1. Pregnant or planning to become pregnant at the time of screening.
  2. 2. Positive cystoscopy within 3 months of screening indicating presence of bladder cancer.
  3. 3. Genitourinary manipulation (flexible or rigid cystoscopy, catheterization, urethral dilation, URS, ureteral stent) within 14 days before urine specimen collection.
  4. 4. History of augmentation cystoplasty.
  5. 5. History of continent cutaneous diversion or ileal conduit.
  6. 6. History of orthotopic bladder substitution or orthotopic neobladder.
  7. 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. 8. New or recurrent NMIBC (non-muscle invasive bladder cancer) diagnosis within three months of study enrollment.
  9. 9. An active malignancy (bladder or other) diagnosis within 3 months of study enrollment.
  10. 10. Patients with a history of NMIBC have undergone intravesical or infusion therapy and completed treatment less than 6 weeks prior to study enrollment.

Contacts and Locations

Principal Investigator

Jeffrey R. Karnes, M.D.
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Pangea Laboratory LLC

  • Jeffrey R. Karnes, M.D., PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2025-06-03
Study Completion Date2027-03

Study Record Updates

Study Start Date2025-06-03
Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

  • Bladder CARE™
  • Bladder Cancer
  • Atypical Cytology
  • Equivocal Cystoscopy
  • Bladder Cancer Detection
  • Hematuria
  • Non-Invasive Urine Test
  • Urological
  • Urology
  • Microhematuria
  • Gross Hematuria
  • Urothelial Carcinoma
  • Bladder Cancer Biomarkers
  • Urinary Biomarker
  • Urologic Oncology
  • Inconclusive Cystoscopy Results
  • Inconclusive Cytology Results
  • Urine-Based Bladder Cancer Detection

Additional Relevant MeSH Terms

  • Bladder Cancer
  • Urothelial Carcinoma Bladder