Generation Victoria Cohort 2020s. A Statewide Longitudinal Cohort of Victorian Children and Their Parents
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150,000
- 试验地点
- 1
- 主要终点
- Number of parents and children enrolled in the GenV Cohort 2020s
研究概览
简要总结
Generation Victoria (GenV) is a longitudinal, population-based study of Victorian children and their parents that will bring together data on a wide range of conditions ,exposures and outcomes. GenV blends study-collected, study-enhanced and linked data. It will be multi-purpose, supporting observational, interventional, health services and policy research within the same cohort. It is designed to address physical, mental and social issues experienced during childhood, as well as the antecedents of a wide range of diseases of ageing. It seeks to generate translatable evidence (prediction, prevention, treatments, services) to improve future wellbeing and reduce the future disease burden of children and adults.
The GenV Cohort 2020s is open to all children born over a two-year period, and their parents, residing in the state of Victoria Australia. The GenV Cohort 2020s is preceded by an Advance Cohort of children born between 5 Dec 2020 and 3 October 2021, and their parents. This comprises all families recruited at GenV's Vanguard hospital (Joan Kirner Women's and Children's) and at birthing hospitals throughout Victoria as GenV scaled up to commence recruiting for the GenV Cohort 2020s. The Advance Cohort have ongoing and full participation in GenV for their lifetime unless they withdraw but may have less complete data and biosamples.
详细描述
GenV aims to create large, parallel whole-of-state birth and parent cohorts for discovery and interventional research. The four cornerstones of GenV's first decade are:
- Consented Cohort - Targeting all Victorian children born in a 2-year period and their parents, with the first major recruitment period targeting newborns and infants
- Biosamples - Curation of residual universal biosamples and collection of new biosamples
- Accessing existing data - Continuously-updated linkage to or ingestion of extensive administrative, service, geospatial and clinical datasets, including prospectively-collected datasets from before the child's birth
- Early School Wave - GenV-led phenomic assessment during the child's early school years.
Additional foundations activities are:
- GenV-collected survey data
- Integrated studies - Collaborative observational or interventional research studies embedded within or alongside GenV, with ethically-supported agreements that include arrangements for data sharing.
- IT and data platforms - to support all GenV activities including user research data access.
GenV focuses on 10 big issues: COVID, healthy pregnancy, healthy newborns, equity, climate & environment, mental health, healthy development, allergy & immunity, infection, and obesity & diabetes, with a cross cutting commitment of population genomics. These focus areas drive current planning for data collection but are not intended to be exhaustive and may change over the life of the project.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of parents and children enrolled in the GenV Cohort 2020s
时间窗: Point of consent until study completion (up to 10 years)
Assessed by analysis of records in the study-specific Participant Relationship Management System (PRMS)
Number of participants with successful data linkage at each wave
时间窗: Point of consent until study completion (up to 10 years)
Assessed by analysis of records in the study-specific Participant Relationship Management System (PRMS), e-Consent platform and GenV data repository
Number of participants with complete data collection at each wave
时间窗: Point of consent until study completion (up to 10 years)
Assessed by analysis of records in the study-specific Participant Relationship Management System (PRMS), e-Consent platform and GenV data repository
Number of participants with the targeted biosamples received at each wave
时间窗: Point of consent until study completion (up to 10 years)
Assessed by analysis of records in the study-specific Participant Relationship Management System (PRMS), e-Consent platform and GenV Laboratory Information Management System (LIMS)
次要结局
- Number of participants involved in concurrent interventional research studies embedded within or alongside GenV(Point of consent until study completion (up to 10 years))
- Number of collaborative observational research studies supported(Point of consent until study completion (up to 10 years))
- Number of collaborative interventional research studies supported(Point of consent until study completion (up to 10 years))
- Number of participants involved in concurrent observational research studies embedded within or alongside GenV(Point of consent until study completion (up to 10 years))
- Number of applications to access and analyse GenV end-user datasets(Point of consent until study completion (up to 10 years))