Guangzhou Women's Health Cohort Study (GWHCS) | NCT05506800

Studies
Guangzhou Women's Health Cohort Study (GWHCS)

NCT05506800

Sponsor

Guangzhou Women and Children's Medical Center

Status

Suspended

Last Update Posted

Feb 23, 2023Actual

Enrollment

1,000,000Estimated

Phase

Not provided

Conditions

Cervical Cancer
Breast Cancer
Lung Cancer
Colorectal Cancer
Endometrial Cancer
Ovarian Cancer
Hypertension
Diabetes
Reproductive Disorder

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to the rebound of the COVID-19 epidemic in the city, we have to suspend the project temporarily.

Expanded Access Info

Start Date

Mar 3, 2016Actual

Primary Completion Date

Jul 21, 2026Estimated

Completion Date

Aug 21, 2026Estimated

First Submitted Date

Aug 12, 2022

First Submission Date that Met QC Criteria

Aug 17, 2022

First Posted Date

Aug 18, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 21, 2023

Last Update Posted Date

Feb 23, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiu Qiu, Head of the Department of Women's Health, Guangzhou Women and Children's Medical CenterPrincipal Investigator

Lead Sponsor

Guangzhou Women and Children's Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The Guangzhou Women's Health Cohort Study aims to explore the health trajectory and factors contributing to the health of women aged 35-64 in Guangzhou. Based on multiple population health registration data platforms, data of the cohort will provide information about the health of women across the lifespan, facilitating the decision-making process by local government . The cohort is progressing steadily, and the goal is to build a large women cohort covering 11 administrative districts of Guangzhou with a scale of 1 million by 2030.

Detailed Description

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,000,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence and mortality rate of cancer	Data from cancer registration platforms	through study completion, an average of 2 years

Secondary Outcomes

Measure	Description	Time Frame
Hypertension and diabetes	Data from questionnaire	through study completion, an average of 2 years
Reproductive health	Data from questionnaire

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women aged 35-64 years old
Women with registered permanent residence in Guangzhou
Women with informed consent

Exclusion Criteria:

Women without informed consent
Women with reading and/or writing difficulties
Women with serious mental disorders

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Women aged 35-64

Minimum Age

35 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Women aged 35-64 years old with registered permanent residence in Guangzhou

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Xiu Qiu, PhD	Guangzhou Women and Children's Medical Center, China	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Guangzhou Women and Children's Medical Center		Guangzhou	Guangdong	510623	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002583	Uterine Cervical Neoplasms
D001943	Breast Neoplasms
D008175	Lung Neoplasms
D015179	Colorectal Neoplasms
D016889	Endometrial Neoplasms
D010051	Ovarian Neoplasms
D006973	Hypertension
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided