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Recruiting NCT06791499

AI-Agent for Automated Diagnosis and Predicting Using EHR and Multimodal Data

Observational AI Agent

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: AI Agent. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

AI-Agent Assisted Automation for Diagnosing and Predicting Patients Using Electronic Health Records and Multimodal Data

Overview

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.

Primary outcome measures

  • Area Under the Curve (AUC) [Time frame: 1 year]
  • F1 Score [Time frame: 1 year]
Secondary outcome measures (2)
  • Sensitivity (True Positive Rate) [Time frame: 1 year]
  • Specificity (True Negative Rate) [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-only

Study locations

China · 6 centers
  • Nanfang Hospital — Guangzhou
  • Sun Yat-Sen Memorial Hospital — Guangzhou
  • Sun Yat-sen University Cancer Hospital — Guangzhou
  • West China Hospital — Chengdu
  • First Affiliated Hospital of Wenzhou Medical University — Wenzhou
  • Second Affiliated Hospital of Wenzhou Medical University — Wenzhou

Identifiers

NCT: NCT06791499 · AI-agent

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗