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ACTIVE NOT RECRUITING

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

NCT06870253 · View on ClinicalTrials.gov ↗

Study 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. 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 Locations (1)

Minnesota

  • Mayo Clinic — Rochester

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2025-06-03
Est. Completion 2027-03

Sponsor

Pangea Laboratory

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06870253

The ClinicalTrials.gov registry entry for NCT06870253 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pangea Laboratory, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Bladder Cancer appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06870253 reports 1 study location spanning 1 distinct geographic area — top geographies include Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06870253 about?

NCT06870253 is a clinical study titled "Evaluating Bladder CARE™, a New Non-Invasive Urine Test, for Bladder Cancer Detection in Inconclusive Cases". 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 pa...

What is the current status of trial NCT06870253?

This trial is currently active not recruiting. The enrollment target is 80 participants. The study started on 2025-06-03. Estimated completion is 2027-03.

What conditions does trial NCT06870253 study?

This clinical trial studies the following conditions: Bladder Cancer, Urothelial Carcinoma Bladder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

Who is sponsoring clinical trial NCT06870253?

This trial is sponsored by Pangea Laboratory, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06870253 being conducted?

This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial