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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06387875
Other study ID # Hangzhou Bay Cohort
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2023
Est. completion date June 30, 2027

Study information

Verified date April 2024
Source RenJi Hospital
Contact Jun Pu, MD, PhD
Phone 86-21-68383477
Email pujun310@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Our objective is to carry out research on prevention and control of noncommunicable chronic diseases, and establish a risk prediction mechanism for chronic diseases to promote early detection, early diagnosis and early treatment of chronic diseases in natural population in Qianwan District of Ningbo, significantly reduce medical costs and extend population life span.


Description:

1. Through baseline survey (cross-sectional survey) and prospective cohort design, the health status information and biological samples of residents in Hangzhou Bay Hospital were collected, and the physical, psychological and social adaptability information was collected through questionnaires and other forms, basic tests and omics measurements were carried out based on the collected samples to build a multi-dimensional data platform. 2. Develop a disease risk prediction model based on big data platform, conduct high-risk population screening and establish risk assessment files; In view of the common health problems in the study population, the key factors and effects of health status were analyzed comprehensively, and the corresponding mathematical model was established to form the prediction of health status. Finally to establish the stratified standard of population health status and provide effective health guidance. Questionnaire survey on epidemiology: The Hangzhou Bay Natural Population Cohort Questionnaire was designed according to the principles and requirements of cohort study. All respondents who entered the cohort will sign informed consent, receive face-to-face interview with uniformly trained investigators, and the questionnaire will be reviewed by quality control personnel for quality control. Physical examination: The examination contents include height, weight, blood pressure, waist circumference, hip circumference, hearing, vision, medical history and surgery, inbody composition, chest film, electrocardiogram, B-ultrasound, non-invasive arteriosclerosis examination, vascular endothelial ultrasound and other imaging examinations. Clinical biochemical test: 5-10 ml of blood, 20 ml of urine and 5 g of feces were collected (if necessary) according to the chronic non-communicable disease spectrum and clinical test requirements in Qianwan New District of Ningbo; The blood samples and urine were tested for biochemistry, liver and kidney function, blood lipids and electrolytes according to clinical testing requirements, as well as multi-omics indicators as needed. 3. Prospective study data: Follow-up of the cohort population (disease occurrence, death, migration, etc.) was conducted through annual active follow-up (telephone, interview, etc.) and passive follow-up, including data of all-cause death, incidence of any kind of diseases.


Recruitment information / eligibility

Status Recruiting
Enrollment 30000
Est. completion date June 30, 2027
Est. primary completion date June 30, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 1) Local permanent residents aged 18 and above (including residents with household registration, or residents without household registration but with a permanent job); - 2) No serious physical disability, can communicate normally; - 3) Participate voluntarily and sign informed consent. Exclusion Criteria: - 1) Temporary resident and floating population; - 2) There are serious health conditions unable to participate in the survey; - 3) Those who are unwilling to accept the follow-up inspection of the project.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Ren Ji Hospital Afflited to School of Medicine, Shanghai Jiao Tong University Shanghai

Sponsors (2)

Lead Sponsor Collaborator
RenJi Hospital Ningbo Hangzhou Bay Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary death Mortality of all-cause disease were calculated by age, gender and area compared by different health management mode. 4 years
Primary incidence of cardio-cerebrovascular diseases Incidence of Cardiovascular and Cerebrovascular diseases were calculated by age, gender and area compared by different health management mode. 4 years
Primary incidence of other non-communicable chronic diseases Incidence of other non-communicable chronic diseases were calculated by age, gender and area compared by different health management mode. 4 years
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