Bladder CancerNCT06870253
Evaluating Bladder CARE™, a New Non-Invasive Urine Test, for Bladder Cancer Detection in Inconclusive Cases
An observational study of Bladder Cancer and Urothelial Carcinoma Bladder, run by Pangea Laboratory LLC at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Bladder Cancer, Urothelial Carcinoma Bladder
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2025to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Urology practice
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
- New or recurrent NMIBC (non-muscle invasive bladder cancer) diagnosis within three months of study enrollment.
- An active malignancy (bladder or other) diagnosis within 3 months of study enrollment.
- Patients with a history of NMIBC have undergone intravesical or infusion therapy and completed treatment less than 6 weeks prior to study enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Bladder Cancer, Urothelial Carcinoma Bladder
- Keywords
- 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
- Medical subject headings
- Urinary Bladder Neoplasms, Hematuria, Carcinoma, Transitional Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate Bladder CARE™ Assay performance for detecting bladder cancer in patients with atypical cytology or equivocal cystoscopy
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.
Measured: From enrollment to the end of the study at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start3 Jun 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pangea Laboratory LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey R. Karnes, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870253
- Sponsor's protocol ID
- PAN001-24 BCA
- Status last verified
- Jan 2026
- First submitted
- 5 Mar 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Bladder CARE™ Assay Utility for the Diagnosis of Bladder Cancer in Patients With Atypical Cytology or Equivocal Cystoscopy
- ClinicalTrials.gov ID
- NCT06870253
- Acronym / sponsor ID
- PAN001-24 BCA
- Conditions
- Bladder Cancer, Urothelial Carcinoma Bladder
- Keywords
- Bladder CARE™, Bladder Cancer, Atypical Cytology, Equivocal Cystoscopy, Bladder Cancer Detection, Hematuria, Non-Invasive Urine Test, Urological
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Pangea Laboratory LLCIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Urology practice
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey R. Karnes, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer and Urothelial Carcinoma Bladder, run by Pangea Laboratory LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.