NCT07625436

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
12mo left

Started Jun 2026

Geographic Reach
1 country

13 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 4, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

June 20, 2026

Expected
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

June 4, 2026

Status Verified

June 1, 2026

Enrollment Period

5 months

First QC Date

May 28, 2026

Last Update Submit

June 3, 2026

Conditions

Rare DisordersRare Diseases

Keywords

Rare DiseasesArtificial IntelligenceClinical Decision Support System (CDSS)Diagnosis

Outcome Measures

Primary Outcomes (1)

  • Top-3 Diagnostic Accuracy

    The percentage of definitive diagnosis is included within the physician's top 3 choices.

    Up to 60 minutes per case (from case presentation to diagnostic report submission).

Secondary Outcomes (6)

  • Diagnosis Time per Case

    Up to 60 minutes per case (from case presentation to diagnostic report submission).

  • Workup Plan Quality

    Up to 60 minutes per case (from case presentation to diagnostic report submission).

  • Physician Reported Usability of the AI-Assisted Diagnostic System

    Up to 60 minutes per case (upon completion of each case reading).

  • Physician Reported Workload

    Up to 60 minutes per case (upon completion of each case reading).

  • Physician Satisfaction

    Up to 60 minutes per case (upon completion of each case reading).

  • +1 more secondary outcomes

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Physicians complete assigned diagnostic tasks with the assistance of AI system in addition to conventional clinical resources.

Other: AI-Assisted Diagnosis

Control Arm

NO INTERVENTION

Physicians complete the assigned diagnostic tasks using conventional clinical resources only (e.g., medical databases and literature), without access to any generative AI tools. This arm reflects routine clinical diagnostic practice.

Interventions

AI-Assisted DiagnosisOTHER

A 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.

Intervention Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Licensed physicians at the junior or senior level affiliated with internal medicine, neurology, pediatrics, and rare disease-related departments.
  • \. Willingness to provide written informed consent, adhere to trial protocols, and complete all required pre-study training prior to enrollment.

You may not qualify if:

  • \. Prior exposure to any of the clinical cases included in the study case library.
  • \. Direct participation in the design or development of the AI model.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Peking Union Medical College Hospital

Beijing, China

Location

Cangzhou Central Hospital

Cangzhou, China

Location

Changchun Sacred Heart Hospital

Changchun, China

Location

Dongguan People's Hospital

Dongguan, China

Location

First People's Hospital of Foshan

Foshan, China

Location

Guizhou Provincial People's Hospital

Guiyang, China

Location

Jilin Central General Hospital

Jilin City, China

Location

The First People's Hospital of Yunnan Province

Kunming, China

Location

Tibet Autonomous Region People's Hospital

Lhasa, China

Location

Tianjin Children's Hospital

Tianjin, China

Location

Wuhai People's Hospital

Wuhai, China

Location

Qinghai Provincial People's Hospital

Xining, China

Location

Zhangzhou Municipal Hospital of Fujian Province

Zhangzhou, China

Location

MeSH Terms

Conditions

Rare DiseasesDisease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Shuyang Zhang

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuyang Zhang

CONTACT

+86-13911667211shuyangzhang103@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President of PUMCH

Study Record Dates

First Submitted

May 28, 2026

First Posted

June 4, 2026

Study Start (Estimated)

June 20, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

June 4, 2026

Record last verified: 2026-06

Locations

CN(13)