Artificial Intelligence-assisted HER2 Expression Assessment in Urothelial Carcinoma Based on Imaging-pathology Omics

Enrolling by invitation

Conditions studied: Urothelial Carcinoma (UC), HER2, Diagnostic

In brief

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.

Key facts

Study ID

NCT07454941

Run by

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

People needed

4000

Starts

2026-03-02

Expected to finish

2030-06-03

Last updated by the study team

2026-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences Beijing — Beijing, Chaoyang District, China

Full record on ClinicalTrials.gov

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