Development and Validation of a Digital Twin-based Clinical Research System (X Town Stage I)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06861283

Enrollment

1500

Registered

2025-03-06

Start date

2025-04-13

Completion date

2025-08-10

Last updated

2025-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Disease

Brief summary

Chronic diseases, characterized by their prolonged duration and slow progression, have emerged as predominant contributors to global morbidity and mortality. The investigators have developed a digital twin-based clinical research system (termed X Town) for chronic diseases, to predict clinical outcomes under various interventions. In this study, the investigators aim to evaluate the reliability of the developed digital twin-based clinical research system in predicting short-term clinical outcomes via virtual and real-world clinical studies.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Age≥18 years old 2. Receiving care at a community health service centre 3. Able to understand and comply with the study procedures 4. Agrees to participate in the study and signs the informed consent form

Exclusion criteria

1. Patients with severe mental illness 2. Patients expected to be unable to complete follow-ups

Design outcomes

Primary

Measure	Time frame	Description
The agreement between the simulated short-term clinical outcomes in the virtual clinical studies and the real-world short-term clinical outcomes in the real-world clinical studies	Within 3 months	We will use three predefined binary metrics to evaluate the agreement: (1) full statistical significance agreement, defined by effect estimates and CIs of the virtual and real-world clinical studies on the same side of the null; (2) estimate agreement, defined by whether effect estimates for the virtual clinical studies fell within the 95% CI for the real-world clinical study results; (3) standardized difference agreement between treatment effect estimates from the real-world clinical studies and the virtual clinical studies, defined by standardized differences (Reference: JAMA. 2023;329(16):1376-1385. doi:10.1001/jama.2023.4221).

Countries

China

Contacts

Primary ContactHuating Li, MD, PhD

huarting99@sjtu.edu.cn+86-17749716891

Outcome results