Prospective Cohort of Integrated Traditional Chinese and Western Medicine in China

NCT07196917 | Not Yet Recruiting DMC

• 1 other identifier: 2023ZD0S09900)
• Study Type: observational
• Target: 1,000,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

To further explore the application prospects of integrated Traditional Chinese and Western medicine in chronic disease prevention and control and health management, this study intends to establish a large, prospective, integrated Traditional Chinese and Western medicine cohort in Hubei Province. This study will conduct long-term follow-up and multi-dimensional data collection to systematically reveal the associations between Traditional Chinese Medicine (TCM) constitution types and chronic diseases, the aging process, and multi-morbidity, thereby developing an integrated health management strategy with local characteristics. This study will fill the current gap in systematic evidence linking TCM constitutions to the prevalence of modern diseases, providing a solid demographic and biological foundation for the integrated development of Traditional Chinese and Western medicine. It will also contribute to meeting the needs for early disease warning, early intervention, and personalized care under the "Healthy China" strategic goal.

Conditions

Cardiovascular Diseases; Respiratory Tract Diseases; Cancer; Endocrine System Diseases; Death

Outcome Measures

Primary Outcomes (2)

• Prospective Cohort of Integrated Traditional Chinese and Western Medicine in China

  From enrollment to the 10-year follow-up

• Incidence of major chronic diseases (coronary heart disease, stroke, diabetes, COPD, lung cancer, colorectal cancer, gastric cancer, liver cancer, and esophageal cancer)

  From baseline (enrollment) to 10-year follow-up Measurement Tool: Standardized physician-adjudicated diagnosis based on ICD-10 codes, confirmed through hospital electronic medical records and disease registries

Secondary Outcomes (1)

• All-cause mortality

  From baseline to 10-year follow-up

Other Outcomes (2)

• Cause-specific mortality (cardiovascular, cancer, respiratory, metabolic)

  From baseline to 10-year follow-up

• Prevalence and progression of multimorbidity (≥2 chronic conditions)

  Baseline to 10-year follow-up

Eligibility Criteria

• Age: 30 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Targeting urban and rural residents across multiple regions in Hubei Province, this study plans to recruit 1 million participants. Standardized protocols will be employed for baseline questionnaire surveys, physical examinations, and biological sample collection.

You may qualify if:

• Age: Participants aged 30 to 74 years
• Physical Functionality: Free from severe physical disabilities impacting mobility or communication, with preserved ability to comprehend and respond to study procedures
• Informed Consent: Capable of providing written informed consent voluntarily after receiving full study disclosure

You may not qualify if:

• Residents living in functional areas (e.g., work sheds, military units, student dormitories, nursing homes, etc.)
• Individuals unable to communicate normally

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Hubei College of Traditional Chinese Medicine: collaborator
• Hubei Hospital of Traditional Chinese Medicine: collaborator
• Hubei Provincial Center for Disease Control and Prevention: collaborator
• Wuhan Center for Disease Control and Prevention: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine

MeSH Terms

Conditions

Cardiovascular Diseases; Respiratory Tract Diseases; Neoplasms; Endocrine System Diseases; Death

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: September 20, 2025
• First Posted: September 29, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 2, 2025

Record last verified: 2025-09