- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07761676
The Cohort Construction Project of Peking University Third Hospital
Study Overview
Status
Intervention / Treatment
Detailed Description
The construction of a health check-up follow-up cohort holds significant importance for public health research. Since its establishment in 2022, the Health Check-up Cohort of Peking University Third Hospital (PUTH) has been operational for three years. The cohort features comprehensive health check-up indicators, including physical examination, biochemical tests, cancer screening, and 13 other major categories of indicators. It is equipped with a robust data management system and collaborates with the Clinical Epidemiology Research Center and the biobank. A multidimensional database has been established, covering health check-up information, health questionnaires, and biological samples of the study subjects. The cohort adopts a bidirectional study design, with the retrospective part covering individuals who underwent health check-ups since 2011 and the prospective part continuously enrolling subjects since 2022. As of 2023, the PUTH Health Check-up Cohort has collected health check-up data from over 80,000 study subjects, with the longest follow-up duration reaching 12 years, forming a longitudinal health database with continuous follow-up.
The cohort construction project has achieved favorable research outcomes, with a total of 14 academic papers published, including 8 SCI papers, and two invention patents granted. In addition, the cohort has collaborated with clinical departments within the hospital and has previously received funding from both internal and external horizontal and vertical projects. The primary focus has been on conducting research on medical reference value ranges and disease prevention and control among the health check-up cohort population. Building on the solid foundation of previous work, the cohort study will continue to optimize and expand, aiming to align with international large-scale cohorts by constructing a health check-up cohort with a large sample size, long follow-up duration, and high follow-up density.
The specific construction goals for this period include enrolling 100,000 individuals for dynamic follow-up, perfecting the biobank by collecting biological samples from 20,000 individuals, and gathering health questionnaire information from 30,000 people. The near-term goals emphasize the use of health check-up data combined with advanced artificial intelligence technologies to build disease prediction models and explore the association between retinal photographs and overall health status, which will assist in early screening and personalized interventions for high-risk populations. The medium- to long-term goals focus on biological age-related research, utilizing telomere length and multi-omics technologies to assess the differences between biological age and chronological age and analyze their key influencing factors. Data collection will be implemented through the health check-up centers of multiple campuses of PUTH.
The construction of this health check-up cohort provides a solid data foundation for the prevention of chronic diseases, individualized health management, and research on healthy aging. Through long-term follow-up and large-scale data collection, it can reveal disease risk factors, develop early prediction models, and in combination with biomarkers and multi-omics technologies, it helps explore the relationship between biological age and health status, promoting the development of precision medicine and the optimization of public health policies.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Liyuan Tao, PhD
- Phone Number: +86 13581552613
- Email: tendytly@163.com
Study Contact Backup
- Name: Honghai He, MPH
- Phone Number: +86 15101049480
- Email: hehonghai2011@126.com
Study Locations
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100191
- Recruiting
- Physical Examination Center, Peking University Third Hospital
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Contact:
- Liyuan Tao, PhD
- Phone Number: +86 13581552613
- Email: tendytly@163.com
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Contact:
- Peng Wang, MMed
- Phone Number: +86 13601015655
- Email: bysywp@126.com
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Principal Investigator:
- Peng Wang, MMed
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Sub-Investigator:
- Liyuan Tao, PhD
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Sub-Investigator:
- Ying Che, MS
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥ 18 years. Participants must be from group health examination populations who have undergone at least two consecutive health examinations at our Physical Examination Center.
Exclusion Criteria:
- Failure to provide informed consent. Incomplete data, including incomplete health examination self-administered questionnaires.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Functional Community Health Examination Cohort
This cohort consists of employees from functional community units (such as government agencies, schools, and enterprises) who undergo regular health examinations at the Physical Examination Center of Peking University Third Hospital.
The cohort integrates both retrospective and prospective data, with long-term follow-up and biospecimen collection (serum) stored in the hospital's biobank.
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This is an observational study designed to investigate the mental health status and its influencing factors in the general physical examination population.
No interventions are assigned to participants based on a protocol.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Systolic and Diastolic Blood Pressure
Time Frame: through study completion, an average of 3 year
|
Blood pressure will be measured using a standardized mercury sphygmomanometer after at least 5 minutes of rest in a seated position.
Both systolic blood pressure (SBP) and diastolic blood pressure (DBP) will be recorded.
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through study completion, an average of 3 year
|
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Fasting Lipid Profile (Total Cholesterol, Triglycerides, LDL-C, and HDL-C)
Time Frame: through study completion, an average of 3 year
|
Venous blood samples will be collected after at least 8 hours of overnight fasting.
Serum levels of total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) will be measured using an automated biochemical analyzer at the central laboratory of Peking University Third Hospital.
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through study completion, an average of 3 year
|
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Fasting Blood Glucose (FBG)
Time Frame: through study completion, an average of 3 year
|
Fasting venous blood samples will be collected after at least 8 hours of overnight fasting.
Serum glucose levels will be measured using an automated biochemical analyzer at the central laboratory of Peking University Third Hospital.
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through study completion, an average of 3 year
|
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Glycated Hemoglobin (HbA1c)
Time Frame: through study completion, an average of 3 year
|
Fasting venous blood samples will be collected and analyzed using high-performance liquid chromatography (HPLC) at the central laboratory of Peking University Third Hospital.
HbA1c reflects average blood glucose levels over the previous 2 to 3 months.
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through study completion, an average of 3 year
|
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Complete Blood Count (CBC)
Time Frame: through study completion, an average of 3 year
|
Fasting venous blood samples will be collected and analyzed using an automated hematology analyzer at the central laboratory of Peking University Third Hospital.
Key parameters include white blood cell count (WBC), red blood cell count (RBC), hemoglobin (HGB), hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), and platelet count (PLT).
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through study completion, an average of 3 year
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Routine Urinalysis
Time Frame: through study completion, an average of 3 year
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Midstream clean-catch urine specimens will be collected and analyzed using an automated urine analyzer and microscopy at the central laboratory of Peking University Third Hospital.
Key parameters include urine specific gravity, pH, protein, glucose, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase, and microscopic examination of red blood cells, white blood cells, and casts.
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through study completion, an average of 3 year
|
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Liver Function Panel
Time Frame: through study completion, an average of 3 year
|
Fasting venous blood samples will be collected and analyzed using an automated biochemical analyzer at the central laboratory of Peking University Third Hospital.
Key parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT), total bilirubin (TBIL), direct bilirubin (DBIL), total protein (TP), and albumin (ALB).
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through study completion, an average of 3 year
|
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Renal Function Panel
Time Frame: through study completion, an average of 3 year
|
Fasting venous blood samples will be collected and analyzed using an automated biochemical analyzer at the central laboratory of Peking University Third Hospital.
Key parameters include serum creatinine (Cr), blood urea nitrogen (BUN), uric acid (UA), and estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI or MDRD equation.
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through study completion, an average of 3 year
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Pulmonary Assessment
Time Frame: through study completion, an average of 3 year
|
Chest X-ray or low-dose chest CT will be performed according to standardized protocols at the Radiology Department of Peking University Third Hospital.
Findings will be interpreted by certified radiologists.
Results will be reported as presence or absence of pulmonary abnormalities (e.g., nodules, infiltrates, or other clinically significant findings).
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through study completion, an average of 3 year
|
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Abdominal Ultrasound Assessment
Time Frame: through study completion, an average of 3 year
|
Abdominal ultrasound will be performed according to standardized protocols at the Radiology Department of Peking University Third Hospital for evaluation of the liver, gallbladder, pancreas, spleen, and kidneys.
Findings will be interpreted by certified radiologists.
Results will be reported as presence or absence of abnormalities in each organ.
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through study completion, an average of 3 year
|
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Carotid Artery Ultrasound Assessment
Time Frame: through study completion, an average of 3 year
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Carotid artery ultrasound will be performed according to standardized protocols at the Radiology Department of Peking University Third Hospital for assessment of carotid intima-media thickness (CIMT) and plaque detection.
CIMT will be measured in millimeters (mm).
Plaque will be reported as present or absent.
All findings will be interpreted by certified radiologists.
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through study completion, an average of 3 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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BMI
Time Frame: through study completion, an average of 3 year
|
Body composition will be measured using bioelectrical impedance analysis (BIA) or dual-energy X-ray absorptiometry (DXA) at the Physical Examination Center of Peking University Third Hospital.
Body mass index (BMI) will be calculated as weight in kilograms divided by height in meters squared (kg/m²).
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through study completion, an average of 3 year
|
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Body Fat Percentage
Time Frame: through study completion, an average of 3 year
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Body composition will be measured using bioelectrical impedance analysis (BIA) or dual-energy X-ray absorptiometry (DXA) at the Physical Examination Center of Peking University Third Hospital.
Body fat percentage (BFP) will be reported as a percentage (%).
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through study completion, an average of 3 year
|
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Visceral Fat Area
Time Frame: through study completion, an average of 3 year
|
Body composition will be measured using bioelectrical impedance analysis (BIA) or dual-energy X-ray absorptiometry (DXA) at the Physical Examination Center of Peking University Third Hospital.
Visceral fat area (VFA) will be reported in square centimeters (cm²).
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through study completion, an average of 3 year
|
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Skeletal Muscle Mass
Time Frame: through study completion, an average of 3 year
|
Body composition will be measured using bioelectrical impedance analysis (BIA) or dual-energy X-ray absorptiometry (DXA) at the Physical Examination Center of Peking University Third Hospital.
Skeletal muscle mass (SMM) will be reported in kilograms (kg).
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through study completion, an average of 3 year
|
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Handgrip Strength
Time Frame: through study completion, an average of 3 year
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Physical fitness will be assessed by trained exercise physiologists at the Physical Examination Center of Peking University Third Hospital using standardized protocols.
Handgrip strength will be measured using a handheld dynamometer and reported in kilograms (kg).
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through study completion, an average of 3 year
|
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Back Strength
Time Frame: through study completion, an average of 3 year
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Back strength will be assessed by trained exercise physiologists at the Physical Examination Center of Peking University Third Hospital using a back dynamometer following standardized protocols.
Results will be measured and reported in kilograms (kg).
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through study completion, an average of 3 year
|
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Vertical Jump Height
Time Frame: through study completion, an average of 3 year
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Vertical jump height will be assessed by trained exercise physiologists at the Physical Examination Center of Peking University Third Hospital using a force platform or jump mat following standardized protocols.
Results will be measured and reported in centimeters (cm).
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through study completion, an average of 3 year
|
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Estimated VO₂max
Time Frame: through study completion, an average of 3 year
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Cardiorespiratory function will be assessed by trained exercise physiologists at the Physical Examination Center of Peking University Third Hospital using standardized protocols.
Estimated maximal oxygen uptake (VO₂max) will be calculated and reported in milliliters per kilogram per minute (ml/kg/min).
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through study completion, an average of 3 year
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Thyroid Function Panel
Time Frame: Measured at baseline and at each annual health examination visit
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Fasting venous blood samples will be collected and analyzed using an automated chemiluminescence immunoassay analyzer at the central laboratory of Peking University Third Hospital.
Key parameters include thyroid-stimulating hormone (TSH), free triiodothyronine (FT3), and free thyroxine (FT4).
Additional parameters (e.g., total T3, total T4, anti-thyroglobulin antibody [TG-Ab], and anti-thyroid peroxidase antibody [TPO-Ab]) may be measured as clinically indicated.
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Measured at baseline and at each annual health examination visit
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Inflammatory Biomarker Panel
Time Frame: Measured at baseline and at each annual health examination visit
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Fasting venous blood samples will be collected and analyzed at the central laboratory of Peking University Third Hospital.
The inflammatory biomarker panel includes high-sensitivity C-reactive protein (hsCRP) measured by immunoturbidimetry, and a panel of serum cytokines (including but not limited to IL-6, TNF-α, IL-10, and IL-17A) measured using a multiplex immunoassay system.
Additional inflammatory markers such as white blood cell count (WBC) and ferritin will also be assessed.
All measurements will be performed following standardized protocols.
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Measured at baseline and at each annual health examination visit
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Peng Wang, MMed, Peking University Third Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BYSYDL2024010
- IRB00006761-M20250131 (Other Identifier: Peking University Third Hospital Medical Science Research Ethics Committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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