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A simple urine test may spot bladder cancer early — a trial puts it to the test

NCT ID NCT07735858

Diagnosis Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This trial is developing a new, non-invasive urine test for bladder cancer. It uses a microfluidic chip to isolate tiny particles called exosomes from urine and analyze their genetic and protein content. The goal is to create a diagnostic model that can detect bladder cancer accurately without needing a tissue biopsy. The test will be developed in one group of patients and then validated in a separate group to see how well it performs.

What this could mean

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

Active substance
Liquid biopsy (urinary exosome analysis via microfluidic chip)
What this could lead to
If successful, this could provide a simple, non-invasive urine test to detect bladder cancer early, potentially reducing the need for invasive biopsies.
What could go wrong
This is an early-stage diagnostic model that needs validation in larger, diverse groups. The test may not be accurate enough to replace standard diagnosis.

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 300 people

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

Started

Oct 2025

Expected to finish

Sep 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

Bladder cancer or other urinary diseases and healthy individuals

Ages

18 years and older

Sex

Anyone

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\. Age ≥18 years. 2\. Patients with bladder cancer confirmed by pathological examination. 3\. Patients with benign urological diseases confirmed by clinical evaluation. 4\. Ability to provide urine samples and relevant clinical information. 5\. Written informed consent provided. Exclusion Criteria: * 1\. History of other malignant tumors, except participants specifically included in the validation cohort. 2\. Severe organ dysfunction. 3\. Glomerulonephritis. 4\. Recent significant urinary tract injury. 5\. Inadequate urine sample availability.

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Conditions

The condition(s) this trial relates to.

urinary bladder carcinoma Urinary Bladder Neoplasms

As listed by the trial registrant

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

Bladder cancer

Contacts and locations

Locations

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021, China

More trials for these conditions

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