- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07761676
The Cohort Construction Project of Peking University Third Hospital
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Liyuan Tao, PhD
- Telefonní číslo: +86 13581552613
- E-mail: tendytly@163.com
Studijní záloha kontaktů
- Jméno: Honghai He, MPH
- Telefonní číslo: +86 15101049480
- E-mail: hehonghai2011@126.com
Studijní místa
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Beijing Municipality
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Beijing, Beijing Municipality, Čína, 100191
- Nábor
- Physical Examination Center, Peking University Third Hospital
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Kontakt:
- Liyuan Tao, PhD
- Telefonní číslo: +86 13581552613
- E-mail: tendytly@163.com
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Kontakt:
- Peng Wang, MMed
- Telefonní číslo: +86 13601015655
- E-mail: bysywp@126.com
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Vrchní vyšetřovatel:
- Peng Wang, MMed
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Dílčí vyšetřovatel:
- Liyuan Tao, PhD
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Dílčí vyšetřovatel:
- Ying Che, MS
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Systolic and Diastolic Blood Pressure
Časové okno: through study completion, an average of 3 year
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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)
Časové okno: through study completion, an average of 3 year
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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)
Časové okno: through study completion, an average of 3 year
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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)
Časové okno: through study completion, an average of 3 year
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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)
Časové okno: through study completion, an average of 3 year
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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
Časové okno: 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
Časové okno: through study completion, an average of 3 year
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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
Časové okno: through study completion, an average of 3 year
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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
Časové okno: through study completion, an average of 3 year
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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
Časové okno: through study completion, an average of 3 year
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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
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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BMI
Časové okno: 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 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
Časové okno: 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
Časové okno: 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.
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
Časové okno: 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.
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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Thyroid Function Panel
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Peng Wang, MMed, Peking University Third Hospital
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- BYSYDL2024010
- IRB00006761-M20250131 (Jiný identifikátor: Peking University Third Hospital Medical Science Research Ethics Committee)
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