Shanghai Pudong Cohort

January 5, 2023 updated by: RenJi Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Cardiology, Ren Ji Hospital
        • Contact:
          • Jun Pu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 second to 120 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Natural Chinese population

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
A cohort as an area probability sample of Shanghai City

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Health Status of the General Population
Time Frame: 10 years
Survey on the general health of the nation in a specific time
10 years
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.
10 years
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.
10 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Normalized management rate of common chronic diseases
Time Frame: 10 years
Normalized management rate of common chronic diseases
10 years
Health questionnaire
Time Frame: 10 years

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.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RenJi Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jun Pu, MD,PhD, Cardiology, Ren Ji Hospital, Shanghai, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 7, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 25, 2022

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Shanghai Pudong Cohort

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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