AI-Based Imaging Model for Bladder Cancer Prediction

Recruiting

• Conditions: Develop a CT-based Tumor Budding Predictive Model for Bladder Cancer Using Deep Learning Algorithms
• Interventions: Other: No specific interventions.

• Registration Number: NCT06442839
• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

Brief Summary

Bladder cancer is the ninth most common malignant tumor worldwide, characterized by high malignancy and poor prognosis. We intend to develop a CT-based tumor budding predictive model for bladder cancer using deep learning algorithms. This model will facilitate preoperative assessment of patient conditions, enabling the formulation of more precise and personalized treatment plans.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study Start: 2024-05-01
• Study First Submitted: 2024-05-30
• Study First Submitted QC: 2024-05-30
• Last Update Submitted: 2024-05-30
• Study First Posted: 2024-06-04
• Last Update Posted: 2024-06-04
• Primary Completion: 2024-10-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

1. Bladder cancer patients treated from January 1, 2014, to January 1, 2023;
2. Hospitalized and underwent transurethral resection of bladder tumor (TURBT) or radical cystectomy;
3. Complete clinical, preoperative CT, and pathological data.

Exclusion Criteria

1. Patients who previously underwent surgical treatment for bladder cancer at other centers, making it difficult to obtain their preoperative data;
2. Patients with other concurrent pelvic or urinary system malignancies;
3. Patients with poor quality, low resolution, or faded CT or pathological images.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
external validation cohort 4	No specific interventions.	used to evaluate the model's performance, is from the Yan'an Hospital Affiliated to Kunming Medical University.
external validation cohort 2	No specific interventions.	used to evaluate the model's performance, is from the Second Affiliated Hospital of Dalian Medical University.
external validation cohort 1	No specific interventions.	used to evaluate the model's performance, is from the Third Affiliated Hospital of Sun Yat-sen University.
internal validation cohort	No specific interventions.	used to evaluate the model's performance, is from Sun Yat-sen Memorial Hospital of Sun Yat-sen University.
training cohort	No specific interventions.	for training the model, from Sun Yat-sen Memorial Hospital of Sun Yat-sen University.
external validation cohort 3	No specific interventions.	used to evaluate the model's performance, is from the First Affiliated Hospital of Chongqing Medical University.

Primary Outcome Measures

Name	Time	Method
Tumor Budding: An Overview	One year after being discharged following surgery	Tumor budding is a histopathological phenomenon observed in various types of cancer, including bladder cancer. It refers to the presence of single cells or small clusters of cells (less than five) at the invasive front of tumors. These buds are indicative of an epithelial-mesenchymal transition (EMT), a process where epithelial cells acquire mesenchymal, invasive characteristics, which is crucial for cancer invasion and metastasis.

Trial Locations

Locations (1)

the Third Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China