Clinical trial NCT06791499: AI-Agent for Automated Diagnosis and Predicting Using EHR and Multimodal Data
Official title: AI-Agent Assisted Automation for Diagnosing and Predicting Patients Using Electronic Health Records and Multimodal Data
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: AI Agent
Keywords: AI agent
Lead sponsor: The Eye Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 2000000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants for this study will be selected from multiple healthcare centers and hospitals that maintain comprehensive electronic health records (EHR) and multimodal imaging data. The study population will include patients who have a variety of diseases or health conditions, with data available for diagnosis and disease progression. Participants will have confirmed diagnoses based on clinical records or imaging data, including but not limited to conditions captured by X-rays, CT scans, MRIs, and ultrasounds. Both those with complex health conditions and those with more common illnesses will be included to evaluate the AI system's diagnostic and predictive capabilities across a broad spectrum of cases.Participants from these centers will provide historical health data, and there will be no active intervention beyond the use of their existing clinical and imaging data for training and testing the AI system.

Brief summary: The goal of this clinical study is to evaluate the effectiveness of an AI agent in diagnosing and predicting diseases using electronic health records (EHR) and multimodal imaging data. The AI agent leverages advanced machine learning algorithms to process and analyze diverse health data sources, aiming to assist healthcare providers in making more accurate diagnoses and predictions.

Detailed description: This multi-center, retrospective clinical study is designed to evaluate the application and effectiveness of an AI agent in the medical decision-making process. The AI agent integrates and analyzes multimodal data, including electronic health records (EHR) and various imaging data (e.g., X-rays, MRIs, CT scans, ultrasounds) to predict and diagnose a range of diseases. By leveraging the power of machine learning and data fusion techniques, the AI agent can identify patterns in large and complex datasets, offering insights that may not be immediately apparent through traditional diagnostic methods.The study will compare the AI agent's diagnostic accuracy and disease prediction capabilities with traditional diagnostic practices to assess its potential benefits in clinical settings. Key questions include whether the AI agent can assist in early diagnosis, predict disease progression, and support healthcare professionals in making personalized treatment decisions. Participants will not be required to undergo any additional interventions; they will only provide historical health data, including EHR and relevant imaging data, which will be analyzed by the AI agent. The AI system will then use this data to assist healthcare providers by offering predictions and diagnostic suggestions based on the analysis of the multimodal information. The ultimate goal is to determine whether this AI-driven approach can improve diagnostic accuracy, optimize treatment strategies, and enhance patient outcomes in clinical practice.

Eligibility criteria: Inclusion Criteria:

1. Participants must have comprehensive electronic health records (EHR) available, including demographic information, medical history, and laboratory results.
2. Participants must have available multimodal imaging data (e.g., X-rays, CT scans, MRIs, ultrasounds) relevant to their health condition.
3. Participants must have a confirmed diagnosis of one or more diseases or health conditions based on clinical records or imaging data.
4. Patients must provide consent for the use of their historical health data for research purposes.

Exclusion Criteria:

1. Participants with ambiguous or unverifiable diagnoses that cannot be accurately categorized.
2. Duplicate or redundant patient data (e.g., repeated records of the same patient without clear differentiation).

Primary outcomes:
measure: Area Under the Curve (AUC)
timeFrame: 1 year
measure: F1 Score
timeFrame: 1 year
Secondary outcomes:
measure: Sensitivity (True Positive Rate)
timeFrame: 1 year
measure: Specificity (True Negative Rate)
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Hospital
state: Guangdong
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
city: Wenzhou
country: China
facility: First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
city: Wenzhou
country: China
facility: Second Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
References: