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Simple DNA test could reveal hidden bladder cancer before surgery

NCT ID NCT06396533

Diagnosis Sponsor: Fox Chase Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether a combined blood and urine DNA test can accurately detect muscle-invasive bladder cancer in patients scheduled for bladder removal surgery. Researchers will compare the test results with the actual findings from surgery. The goal is to see if this non-invasive test can help doctors decide on the best surgical approach. About 92 adults with various stages of bladder cancer are being enrolled.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
blood and urine DNA test (ctDNA and cfDNA assay)
What this could lead to
If successful, this test could help doctors better identify which bladder cancer patients need more aggressive surgery, potentially improving outcomes.
What could go wrong
This is an early-stage diagnostic trial with only 92 participants, so the test may not be accurate enough for widespread use. It is not a treatment and does not directly improve survival.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 92 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients who are planned for cystectomy due to bladder cancer will be considered for enrollment based on inclusion and exclusion criteria. Eligible patients will have bio specimen collected in accordance with the trial protocol.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Properly counselled patients with high grade T1 disease who elect for cystectomy 2. Properly counselled patients with non-muscle invasive high grade Ta urothelial carcinoma or carcinoma in situ who are unresponsive to intravesical therapy and have elected cystectomy 3. cT2-T3 muscle invasive urothelial carcinoma for planned cystectomy 4. Patient who have received prior intravesical therapy or multiple TURBTs can be enrolled (data regarding number of previous TURBTs and type of intravesical therapy will be collected). 5. Male or female patients age \>=18 years at the time of consent. 6. Able and willing to comply with study requirements. 7. Patients must have a non-contrast phase component for CT scans of chest/abdomen/pelvis either pre-existing (prior to accrual) or obtained during the screening process. 8. Patients who undergo neoadjuvant systemic therapy for muscle invasive disease must be enrolled before starting systemic therapy. 9. Ability to understand and willingness to sign a written informed consent and HIPAA authorization document. Exclusion Criteria: 1. Patients who undergo cystectomy with non-curative intent will be excluded. 2. Patients who have undergone previous definitive pelvic radiation for the purpose of treating bladder malignancy. 3. Patients who are pregnant or nursing.

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Conditions

The condition(s) this trial relates to.

infiltrating bladder urothelial carcinoma non-invasive bladder urothelial carcinoma transitional cell carcinoma urothelial carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Muscle invasive bladder urothelial carcinoma Non-muscle invasive bladder urothelial carcinoma Urothelial carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fox Chase Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19111, United States

  • University of Nebraska Medical Center

    RECRUITING

    Omaha, Nebraska, 68198, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.