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Urine test aims to spot urological cancers without invasive scopes

NCT ID NCT07813260

Diagnosis Sponsor: Ruijin Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

Researchers are testing a urine-based fluorescence assay to see if it can detect urological cancers in people who have blood in their urine. The study enrolls 170 adults scheduled for cystoscopy or ureteroscopy. Urine samples are collected before endoscopy and analyzed with the assay and a DNA ploidy test, then compared with biopsy results. The goal is to measure how accurately the urine test identifies cancers and rules them out.

What this could mean

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

Active substance
a urine-based immunofluorescence cytology test
What this could lead to
If the test performs well, it could offer a non-invasive way to screen for urological cancers in people with blood in their urine, potentially reducing the need for invasive procedures.
What could go wrong
The test may miss cancers or produce false alarms, and the study is small and single-center, so results may not apply broadly. It is a diagnostic accuracy study, not a treatment trial.

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 170 people

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

Started

Apr 2026

Expected to finish

Apr 2027

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 presenting with hematuria who are scheduled for endoscopic evaluation (cystoscopy/ureteroscopy) for suspected urological malignancies (including bladder, renal pelvic, ureteral, and renal cell cancers) at a single urology center in Shanghai, China.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Presenting with hematuria requiring urological malignancy workup Age ≥ 18 years Planned to undergo cystoscopy and/or ureteroscopy Able to provide written informed consent Exclusion Criteria: * Prior confirmed diagnosis of urological malignancy Participation in another clinical trial within 3 months prior to enrollment Any clinical condition that, per investigator judgment, may interfere with study execution Inadequate urine sample quality or volume

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Conditions

The condition(s) this trial relates to.

renal pelvis/ureter urothelial carcinoma urethra transitional cell carcinoma urothelial carcinoma

As listed by the trial registrant

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

Uc (urothelial cancer) UTUC

How to take part

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  1. The places running it

    1 site. 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

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Contacts and locations

Locations

  • Ruijin Hospital

    RECRUITING

    Shanghai, China

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