AI-assisted Rare Disease Diagnosis

StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary endpoint removed 2 → 1 primary endpoints
Primary endpoint reworded 1 of 2 changed
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Record History

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  1. Recruitment opened Show 4 more changesShow less
    • Study sites: 13 to 12
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 2 of 7 entries
    • Collaborators: 8 to 10
  2. Re-verified, no change to tracked fieldsv4
  3. Primary endpoint(s) modified
    • Primary endpoint(s) modified
    • Secondary endpoints: 15 to 7
    • Study description expanded, about 25 words
    v3
  4. Start date: Jun 20, 2026 to Aug 1, 2026v2 Show 7 more changesShow less
    • Primary endpoints revised (2)
    • Enrollment target: 1055 to 1056
    • Secondary endpoints: 10 to 15
    • Study description shortened, about 35 words
    • Study sites revised (13)
    • Collaborators: 9 to 8
    • Study title shortened, about 4 words
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT07650799
Lead Sponsor Peking Union Medical College Hospital
Collaborators: Cangzhou Central Hospital, Zhangzhou Municipal Hospital, Dongguan People's Hospital, First People's Hospital of Foshan, Guizhou Provincial People's Hospital, Tianjin Children's Hospital, The First People's Hospital of Yunnan, Qinghai People's Hospital, Tianshui 407 Hospital, Jilin city central hospital
Conditions
(from sponsor)		 Rare Disorders, Rare Diseases
Related terms Disease, Rare Diseases
Enrollment 1,056 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov