Public HealthNCT05206643
Shanghai Pudong Cohort
An observational study of Public Health, run by RenJi Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Public Health
- How many people
- 80,000 participants
- Where
- 1 siteChina
- Study dates
- 7 Aug 2019to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 120 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Natural Chinese population
Who may be able to join
- 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.
Who cannot join
- severely ill or too frail to answer; or having cognitive problems; having hearing or speaking problems; or dementia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Shanghai Pudong Natural Population-based Cohort Establishment and Follow-up
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.
Read the 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:
- 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.
- 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.
- 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.
- 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.
- Conditions
- Public Health
- Keywords
- Cohort Study, Natural Population, China
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A cohort as an area probability sample of Shanghai City | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Status of the General Population
Survey on the general health of the nation in a specific time
Measured: 10 years
Incidence of common chronic diseases
Incidence of common chronic diseases including cardio-cerebrovascular diseases, cancers and metabolic diseases were calculated by age, gender and area compared by different health management mode.
Measured: 10 years
Mortality of common chronic diseases
Mortality of common chronic diseases including cardio-cerebrovascular diseases, cancers and metabolic diseases were calculated by age, gender and area compared by different health management mode.
Measured: 10 years
Secondary outcomes (2)
Normalized management rate of common chronic diseases
Normalized management rate of common chronic diseases
Measured: 10 years
Health questionnaire
General health questionnaire including questions about chronic diseases, lifestyle, access to health services, comorbidities, mental health, smoke, alcohol and drugs consumption. Additional questions regarding more specific themes (ASCVD, medical aid in dying, COVID-19, etc.) will be added or adapted yearly.
Most of the questions are individually based on previously accepted or previously used questionnaires and thus, the health questionnaire used in this project does not include a specific scale of measurement for each subject.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start7 Aug 2019
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Public HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jinqiao Community Health Service Center of Pudong new area, Shanghai, Heqing Community Health Service Center of Pudong new area, Shanghai, Weifang Community Health Service Center of Pudong new area, Shanghai, Jinyang Community Health Service Center of Pudong new area, Shanghai
- Responsible party
- Sponsor
- Investigators
- Jun Pu, MD,PhD, Principal investigator, Cardiology, Ren Ji Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206643
- Sponsor's protocol ID
- Shanghai Pudong Cohort
- Status last verified
- Jan 2022
- First submitted
- 11 Jan 2022
- Last updated
- 9 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shanghai Pudong Natural Population-based Cohort Establishment and Follow-up
- ClinicalTrials.gov ID
- NCT05206643
- Acronym / sponsor ID
- Shanghai Pudong Cohort
- Conditions
- Public Health
- Keywords
- Cohort Study, Natural Population, China
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80,000 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Jinqiao Community Health Service Center of Pudong new area, Shanghai, Heqing Community Health Service Center of Pudong new area, Shanghai, Weifang Community Health Service Center of Pudong new area, Shanghai, Jinyang Community Health Service Center of Pudong new area, Shanghai
- Study start
- 7 Aug 2019 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 25 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A cohort as an area probability sample of Shanghai City | – | – |
Who may qualify
- Ages
- 0 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Natural Chinese population
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- severely ill or too frail to answer; or having cognitive problems; having hearing or speaking problems; or dementia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Health Status of the General Population
Time frame: 10 years
Survey on the general health of the nation in a specific time
Incidence of common chronic diseases
Time frame: 10 years
Incidence of common chronic diseases including cardio-cerebrovascular diseases, cancers and metabolic diseases were calculated by age, gender and area compared by different health management mode.
Mortality of common chronic diseases
Time frame: 10 years
Mortality of common chronic diseases including cardio-cerebrovascular diseases, cancers and metabolic diseases were calculated by age, gender and area compared by different health management mode.
2 secondary outcomes
Normalized management rate of common chronic diseases
Time frame: 10 years
Health questionnaire
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Public Health
Not yet recruitingObservational study
Factors Influencing Adoption of a Novel Malaria Treatment in Côte d'Ivoire, Ghana, and Rwanda
Malaria
Active, not recruiting
Community Health Equity Accelerator (CHEA) Pediatric Asthma Intervention
Asthma in Children
Active, not recruiting
Growing Healthy Children and Families in Rural Arkansas
Pediatric Obesity, Health Behavior, Risky
Active, not recruiting
Conquering Hypertension in Urban Vietnam
Hypertension
Enrolling by invitation
Randomized Controlled Trial Of Text Messages To Increase Pneumococcal Vaccination In Adults In Chile.
Pneumococcal Infections, Immunization Programs
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Pu, MD,PhD principal investigator
Cardiology, Ren Ji Hospital, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Public Health, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Pu, MD,PhD (86-21-68383477, pujun310@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Status of the General Population (time frame: 10 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2023.