Artificial Intelligence-assisted HER2 Expression Assessment in Urothelial Carcinoma Based on Imag… (NCT07454941) | Clinical Trial Compass
By InvitationNot Applicable
Artificial Intelligence-assisted HER2 Expression Assessment in Urothelial Carcinoma Based on Imaging-pathology Omics
China4,000 participantsStarted 2026-03-02
Plain-language summary
This study aims to build upon previous research by using artificial intelligence methods to fuse multimodal data from imaging and pathology to construct a predictive model for HER2 expression in urothelial carcinoma. The model's performance will be validated and optimized using a multicenter 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. Big data analysis and deep learning will also assist physicians in more accurately diagnosing the disease and developing personalized treatment plans. The research findings will promote the integration and development of artificial intelligence technology with the healthcare industry in the application of multimodal data from clinical, imaging, and pathology perspectives.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Artificial intelligence predicts HER2 expression in urothelial carcinoma
Timeframe: Through study completion, an average of 24 months
Trial details
NCT IDNCT07454941
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences