Artificial Intelligence for Rare Disease Diagnosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking Union Medical College Hospital
About this trial
A multicentre, randomised diagnostic accuracy study to evaluate whether the rare disease-specific AI can improve diagnostic accuracy and efficiency for physicians managing real-world clinical cases.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
1. Licensed physicians at the junior or senior level affiliated with internal medicine, neurology, pediatrics, and rare disease-related departments.
2. Willingness to provide written informed consent, adhere to trial protocols, and complete all required pre-study training prior to enrollment.
Disqualifiers
1. Prior exposure to any of the clinical cases included in the study case library.
2. Direct participation in the design or development of the AI model.
Trial design
Design model
Crossover
Treatments tested in this trial
AI-Assisted Diagnosis
Other interventionA rare disease-specific diagnostic AI model is used to accept free text input and assist in rare disease diagnoses. During the experimental condition, physicians may interact with the system freely alongside standard clinical resources to support their diagnostic reasoning.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Intervention ArmExperimental treatment 1 intervention
Group B: Control ArmNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Top-3 Diagnostic Accuracy
The percentage of definitive diagnosis is included within the physician's top 3 choices.
Time frame
Up to 60 minutes per case (from case presentation to diagnostic report submission).Secondary outcomes
1
Diagnosis Time per Case
Elapsed time from initial case presentation to final diagnostic report submission, recorded automatically via system logs.
Time frame
Up to 60 minutes per case (from case presentation to diagnostic report submission).2
Workup Plan Quality
Quality score of the clinical workup plan assigned by an independent expert committee using a standardized Likert Scale. Scores range from 1 to 10, with higher scores indicating better workup plan quality.
Time frame
Up to 60 minutes per case (from case presentation to diagnostic report submission).3
Physician Reported Usability of the AI-Assisted Diagnostic System
Physician-reported usability of the AI system, assessed after completion of each AI-assisted case reading using a 10-point physician-rated usability scale. Scores range from 1 to 10, with higher scores indicating better system usability.
Time frame
Up to 60 minutes per case (upon completion of each case reading).4
Physician Reported Workload
Task-related workload experienced by physicians, assessed after completion of each AI-assisted case reading using a 10-point Physician Workload Likert scale. Scores range from 1 to 10, with higher scores indicating a higher workload.
Time frame
Up to 60 minutes per case (upon completion of each case reading).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Peking Union Medical College Hospital
Lead sponsor
Cangzhou Central Hospital
Collaborator
Zhangzhou Municipal Hospital of Fujian Province
Collaborator
Dongguan People's Hospital
Collaborator
First People's Hospital of Foshan
Collaborator
Tibet Autonomous Region People's Hospital
Collaborator
Guizhou Provincial People's Hospital
Collaborator
Tianjin Children's Hospital
Collaborator
The First People's Hospital of Yunnan
Collaborator
Qinghai People's Hospital
Collaborator
Source ClinicalTrials.gov
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