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

NCT06861283 | Recruiting

• 1 other identifier: 2025-KY-025(K)
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Disease

Outcome Measures

Primary Outcomes (1)

• 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

  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).

  Within 3 months

Study Arms (2)

Virtual clinical studies

Real-world clinical studies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

We will mainly include participants at high-risk of or with chronic diseases.

You may qualify if:

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

You may not qualify if:

• Patients with severe mental illness
• Patients expected to be unable to complete follow-ups

Sponsors & Collaborators

• Shanghai 6th People's Hospital: lead
• Tsinghua University: collaborator
• Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (1)

Shanghai Health and Medical Center

Wuxi, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Huating Li, MD, PhD

CONTACT

+86-17749716891; huarting99@sjtu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: March 6, 2025
• Study Start: April 13, 2025
• Primary Completion: July 10, 2025
• Study Completion: August 10, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-02

Locations

CN (1)