MedTrace Logo

AI-assisted Rare Disease Diagnosis

NCT07650799 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1056

Last updated 2026-07-31

No results posted yet for this study

Summary

A multicentre randomised controlled trial evaluating whether a rare-disease diagnostic large language model can improve diagnostic quality, efficiency, and health-economic outcomes for physicians managing patients with suspected rare or diagnostically unresolved disease.

Conditions

Interventions

OTHER

AI system

The study AI system will be used to provide diagnostic support during the clinical encounter, including structuring relevant clinical information, generating a clinical analysis, and suggesting candidate diagnoses for review by the treating physician.

Sponsors & Collaborators

  • Cangzhou Central Hospital

    collaborator OTHER

  • Zhangzhou Municipal Hospital

    collaborator OTHER

  • Dongguan People's Hospital

    collaborator OTHER_GOV

  • First People's Hospital of Foshan

    collaborator OTHER

  • Guizhou Provincial People's Hospital

    collaborator OTHER

  • Tianjin Children's Hospital

    collaborator OTHER

  • The First People's Hospital of Yunnan

    collaborator OTHER

  • Qinghai People's Hospital

    collaborator OTHER

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Shuyang Zhang, MD, PhD · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
0 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2027-07-01
Completion
2027-12-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07650799 on ClinicalTrials.gov