Performance of AI Models in the Clinical Pathology Diagnostic Workflow: A Multicenter, Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,060
- 试验地点
- 3
- 主要终点
- Area under ROC curve (AUC)
研究概览
简要总结
The investigators plan to conduct a multicenter, prospective, randomized controlled trial to systematically evaluate the incremental value of pathology-based artificial intelligence (AI) models in a pan-disease diagnostic workflow. The study will primarily compare interpretation using an AI-assisted platform with conventional independent slide reading in terms of diagnostic accuracy (e.g., AUC), reading efficiency (e.g., diagnostic time), diagnostic report quality, diagnostic confidence (Likert scale), and pathologists' satisfaction with the AI model. Investigators will also assess superiority among less experienced (junior) pathologists and non-inferiority among more experienced (senior) pathologists. Successful completion of this project will provide high-level prospective evidence to support standardized deployment, quality control, and broader implementation of pathology AI in clinical practice. This trial may also evaluate the potential benefits and risks of using AI tools in medical research.
详细描述
In this study, investigators plan to enroll 60 pathologists with varying levels of experience and 2,000 patients requiring pathological diagnosis, with whole-slide images (WSIs) collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pathologists:
- •Inclusion Criteria:
- •Voluntarily provide written informed consent.
- •Age ≥ 20 years.
- •Have completed at least 1 year of training in pathological diagnosis.
排除标准
- •Individuals with reading difficulties or a reading disorder.
- •Unwilling to participate in this study.
- •Inclusion Criteria:
- •Voluntarily provide written informed consent.
- •Age ≥ 18 years.
- •Have available digital pathology images and relevant clinical information.
- •Exclusion Criteria:
- •Missing data or data quality not meeting the requirements for analysis.
- •Deemed unsuitable for participation by the investigator.
- •Unwilling to participate in this study.
研究组 & 干预措施
AI-assisted group
Pathologists in this group are required to use the AI pathology diagnostic model to assist their diagnoses. The AI pathology model will provide a predicted result for each case.
干预措施: AI model (Other)
Independent Diagnosis Group (Control Group)
In this group, pathologists will independently diagnose each case based on their own clinical experience, and will record both their time to diagnosis and their diagnostic confidence.
干预措施: Control (Other)
结局指标
主要结局
Area under ROC curve (AUC)
时间窗: Assessments will be conducted within one week after the pathologists' diagnoses
Area under the curve
次要结局
- Diagnostic time per case(Measured immediately after the pathologists' diagnosis)
- Pathologists' diagnostic confidence(At the time of diagnosis for each case.)