Construction of a Deep Learning-Based Precise Diagnostic Framework for Bladder Tumors Using Ultrasound: A Multicenter, Ambispective Cohort Study (BCA-AI-US)

Peking University

Status: Enrolling

Conditions: Deep Learning; Bladder Cancer; Ultrasound

Treatments: Other: observational diagnostic model development

Study type: Observational

Funder types: Other

Identifiers

NCT07111364

BCA-AI-US

Details and patient eligibility

About

This study aims to develop an ultrasound image-based deep learning system to enable automatic segmentation, T-staging, and pathological grading prediction of bladder tumors. It seeks to enhance the objectivity, accuracy, and efficiency of bladder cancer diagnosis, reduce reliance on physician experience, and provide support for precision medicine and resource optimization.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:① Suspected bladder mass detected by abdominal ultrasound (age ≥18 years);② Patients scheduled for surgical treatment of bladder tumors.

Exclusion Criteria:

• Age >85 years;

  • Patients unable to undergo abdominal/transrectal ultrasound (e.g., uncooperative individuals, technically inadequate images);

    • History of bladder tumor surgery, radiotherapy, chemotherapy, or systemic therapy within 3 months; ④ Patients with indwelling medical devices (e.g., double-J ureteral stents, urinary catheters);

      • Failure to undergo bladder tumor surgery within 2 weeks post-ultrasound; ⑥ Non-urothelial carcinoma or pathologically unconfirmed diagnoses.