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AI could replace biopsies for bladder cancer testing

NCT ID NCT07454941

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study enrolls 4,000 people with urothelial carcinoma to test whether artificial intelligence can predict HER2 expression using MRI scans and pathology images. The goal is to create a model that accurately assesses HER2 status without needing invasive biopsies, helping doctors decide on targeted therapy faster. Researchers will also use AI to diagnose tumor type, grade, and invasiveness from pre-treatment images.

What this could mean

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

Active substance
Artificial intelligence model
What this could lead to
If successful, this AI model could quickly and accurately predict HER2 status from MRI scans, helping doctors choose the right targeted therapy without needing a biopsy.
What could go wrong
This is an early-stage model validation study, not a treatment trial. The AI may not be accurate enough in real-world settings, and results may not apply to all patients or hospitals.

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 4,000 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Jun 2030

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

We collected imaging and pathological data from patients diagnosed with urothelial carcinoma. Using artificial intelligence, we fused multimodal data from imaging and pathology to construct a predictive model for HER2 expression in urothelial carcinoma. The model's performance was validated and optimized using a multi-center cohort study, ultimately achieving accurate and rapid prediction of HER2 expression. This will guide precise decision-making for further HER2-targeted therapy and improve patient prognosis.

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: * Age ≥ 18 years. * Patients pathologically diagnosed with urothelial carcinoma. * Possession of pre-biopsy or pre-operative multiparametric MRI raw data. * Possession of corresponding paraffin-embedded tissue blocks and digital whole-section images. * Possession of HER2 status report confirmed by immunohistochemistry. * Signed informed consent form. Exclusion Criteria: * Contraindications to MRI, such as presence of metallic implants or claustrophobia. * Patients with missing baseline clinical or pathological information. * Patients who have received neoadjuvant therapy. * Patients with a history of other malignant tumors. * Patients with mixed or non-urothelial carcinoma pathology.

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Conditions

The condition(s) this trial relates to.

disease transitional cell carcinoma urothelial carcinoma

As listed by the trial registrant

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

Diagnostic HER2 Urothelial carcinoma (UC)

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences Beijing

    Beijing, Chaoyang District, 100021, China

More trials for these conditions

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