Clinical trial NCT05206643: Shanghai Pudong Cohort
Official title: Shanghai Pudong Natural Population-based Cohort Establishment and Follow-up
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Public Health
Keywords: Cohort Study
Natural Population
China
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Jinqiao Community Health Service Center of Pudong new area, Shanghai
name: Heqing Community Health Service Center of Pudong new area, Shanghai
name: Weifang Community Health Service Center of Pudong new area, Shanghai
name: Jinyang Community Health Service Center of Pudong new area, Shanghai
First posted: 2022-01-25
Enrollment: 80000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Natural Chinese population

Brief summary: This is a community-based, prospective longitudinal epidemiologic study. Our objective is to establish a natural population-based cohort in Shanghai, China based on the latest scientific researches, preliminary findings of the project team, and a close cooperation model of the Specialist Medical Consortium.

We will focus on the information and management of health status of the general population of all ages (from birth to older age). We plan to integrate the questionnaire data and sample database information into the public health information platform, in order to establish a whole health management system across the lifespan in Chinese Natural Population.

Detailed description: Evidence-based public health approaches to prevent various chronic diseases among population of all ages have been confirmed in recent decades. Yet barriers to implement prevention approaches persist as a result of lack of knowledge about the regularity of changes in health status of people of all ages. The purpose of this study was to learn how best to promote the adoption of evidence based public health practice related to chronic disease prevention.

The whole research plan is based on a prospective cohort study.

Our previous retrospective cohort study collected historical information of the studied cohort from 2014 to 2018 from secondary medical units, residents' community health service centers, emergency departments, and their Healthrecords. Patients' past chronic diseases such as atherosclerotic cardiovascular diseases, cancers, hypertension, diabetes, heart failure, atrial fibrillation, metabolic syndrome and other metabolic diseases, information on the history of drug use, and lifestyle (if any) were collected and sorted out. Moreover, information on various chronic disease morbidity and death among members of the cohort were also collected.

The prospective cohort building on the baseline research conducted during 2019-2020. A total of 851 parameters including physical parameters as well as genetic, biologic, demographic, and psychosocial parameters were included. Specifically, baseline research contains the following procedures:

1. Epidemiological survey: Design the Public Health and Chronic Disease Prevention and Control Questionnaire in accordance with the principles and requirements of the cohort study. On the premise of informed notification, data are collected through face-to-face interviews between the studied cohort and investigators who signed the informed consent and received uniform training. Quality control staff will review the questionnaire for quality control. The main content includes demographic sociology, lifestyle, physical exercise, daily eating habits, usage of dietary supplements, personal and family medical history, psychological assessment, and female fertility history.
2. Physical examination: the examination is performed by the clinical professional physician in the health service center. The examination content includes height, weight, blood pressure, hearing, vision, internal surgery, body fat composition (optional), chest radiography, electrocardiogram, B-ultrasound, carotid ultrasound (optional), and other imaging examinations.
3. Clinical biochemical test: fasting blood collection should be performed by all individuals upon their enrollment. The blood samples collected are tested for biochemistry, liver and kidney function, blood lipid analysis, CMV/EBV/HBV DNAs and antibodies, hsCRP, and electrolyte analysis in accordance with clinical testing requirements.
4. Biological specimen collection: collect 10ml blood samples using a health checkup, then send them to Renji sample bank for separation within 2 hours, and store in -80℃ ultra-low temperature refrigerator. The blood samples are for multi-omics and serological studies.

The follow-up would be conducted from 2020 to 2030. Through annual active (phone, face-to-face interview, etc.) and passive follow-ups, we will collect the information and management of health status of the general population of all ages. Meanwhile, we will track the various chronic diseases occurrence, death, migration, etc. in our cohort. And we will collect data that matches its baseline value, analyze the morbidity and mortality of the cohort population, and grasp the morbidity, the order of the diseases, mortality, and order of the cause of death for each disease.

Eligibility criteria: Inclusion Criteria:

* 0\~120-year-old verified urban and rural residents in Pudong District, Shanghai
* Able to give informed consent (or has a legal designee) All the selected samples were to be interviewed.

Exclusion Criteria:

severely ill or too frail to answer; or having cognitive problems; having hearing or speaking problems; or dementia.

Primary outcomes:
measure: Health Status of the General Population
timeFrame: 10 years
measure: Incidence of common chronic diseases
timeFrame: 10 years
measure: Mortality of common chronic diseases
timeFrame: 10 years
Secondary outcomes:
measure: Normalized management rate of common chronic diseases
timeFrame: 10 years
measure: Health questionnaire
timeFrame: 10 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Cardiology, Ren Ji Hospital
Study officials:
affiliation: Cardiology, Ren Ji Hospital, Shanghai, China
name: Jun Pu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: