Generation Victoria (GenV) Cohort 2020s: A Longitudinal Cohort Study of Victorian Babies and Their Parents

Sponsor

Murdoch Childrens Research Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT05394363

Collaborator

Paul Ramsay Foundation (Other), Royal Children's Hospital (Other), Victoria State Government (Other), Royal Children's Hospital Foundation (Other), University of Melbourne (Other), National Health and Medical Research Council, Australia (Other), The Medical Research Future Fund (Other), Angliss Health Service (Other), Bairnsdale Regional Health Service (Other), Ballarat Health Services (Other), Bass Coast Regional Health (Other), The Bays Private Hospital (Other), Benalla & District Memorial Hospital (Other), Bendigo Hospital (Other), Box Hill Hospital (Other), Cabrini Private Hospital (Other), Casey Hospital (Other), Castlemaine Hospital (Other), Central Gippsland Health Service (Other), Colac Area Health (Other), Dandenong Hospital (Other), Djerriwarrh Health Service (Other), East Grampians Health Service (Other), Echuca Regional Health (Other), Epworth Freemason's Private Hospital (Other), Frances Perry Private Hospital (Other), Peninsula Health (Other), Epworth Geelong (Other), Geelong University Hospital (Other), Goulburn Valley Health (Other), Hamilton Base Hospital (Other), Jessie McPherson Private Hospital (Other), Joan Kirner Women's and Children's Hospital (Other), The Kilmore & District Hospital (Other), Latrobe Regional Hospital (Other), Leongatha Memorial Hospital (Other), Mansfield District Hospital (Other), Maryborough District Health Service (Other), Mercy Hospital for Women (Other), Mercy Werribee Public Hospital (Other), Mildura Base Hospital (Other), Mitcham Private Hospital (Other), Monash Medical Centre (Other), Northeast Health Wangaratta (Other), The Northern Hospital (Other), Northpark Private Hospital (Other), Peninsula Private Hospital (Other), Royal Women's Hospital (Other), Sandringham & District Memorial Hospital (Other), South Gippsland Hospital (Other), South West Healthcare Camperdown (Other), South West Healthcare Warnambool (Other), St John of God Hospital Ballarat (Other), St John of God Hospital Bendigo (Other), St John of God Hospital Berwick (Other), St John of God Hospital Geelong (Other), St Vincents Private Hospital (Other), Swan Hill District Hospital (Other), Waverley Private Hospital (Other), West Gippsland Healthcare Group (Other), Wimmera Base Hospital (Other), Albury Wodonga Health (Other), Yarrawonga District Health Service (Other)

200,000

Enrollment

Location

143.9

Anticipated Duration (Months)

1389.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 babies born over a two-year period, and their parents, residing in the state of Victoria Australia. The GenV Cohort 2020s is preceded by a Vanguard cohort of babies 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 Vanguard cohort have ongoing and full participation in GenV for their lifetime unless they withdraw but may have less complete data and biosamples.

Condition or Disease	Intervention/Treatment	Phase
Mental Health Child Wellbeing Infant Health Child Health Reproductive Health Healthy Aging Health Equity Quality of Life Social Determinants of Health Environmental Exposure Genetics Cognition Learning Child Development Congenital Abnormalities Disability Injuries Communicable Diseases Noncommunicable Diseases Physical Fitness Diet Obesity Allergy and Immunology Inflammation Intergenerational Relations

Detailed Description

GenV aims to create large, parallel whole-of-state birth and parent cohorts for discovery and interventional research. GenV's key features ('building blocks') are:

Consent - Consent soon after birth, targeting every family having a baby in Victoria across in a 2-year period;
Biosamples - Curation of universal biosamples already collected and stored, and new biosamples collected directly by GenV;
Linked data - Ongoing access to extensive administrative, service, clinical and geospatial datasets, including prospectively-collected preconception and prenatal datasets;
GenV-collected data - Information collected from participants via GenV and/or in partnership with services, and face-to-face direct assessment once at school;
Integrated studies - Collaborative research involving GenV participants in concurrent research studies embedded within or alongside GenV, with ethically supported agreements and data sharing arrangements (for example, trials, other interventional studies, depth sub-cohorts, registry-type research);
Platform as a service - Safe and efficient platforms and processes that support diverse users to access and/or analyse the resources and datasets generated by GenV to maximise their benefit to human health, and support GenV to meet its commitment to transparency and Open Science.

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.

GenV is working with partners at all birthing hospitals across Victoria (ie 58 hospital sites). Recruitment visits are completed by trained study staff with clinical and/or research backgrounds at the participant's hospital or via virtual and/or self-guided recruitment after discharge (including initial GenV-collected data and biosamples). Participant-provided data will be collected digitally (e.g. via website or smart phone app) about four times per year from age 3 months to 5 years and is expected to take 3-20 minutes per session. A face-to-face visit is planned for when the index child is around 6 years of age, completed by trained study staff with clinical and/or research backgrounds. The project duration is expected to be at least 10 years and potentially lifelong for its participants, dependant on study funding and willingness to continue.

Based on Victoria's annual birth rate and estimated post-pandemic fall, GenV estimates that the sampling frame for the main Cohort 2020s will comprise 150,000 children, 150,000 'primary' biological parents, and 130,000 (i.e. for 90 percent of children) second parents. GenV is preparing for a recruitment sample of up to 90 percent of children while recognising that uptake as low as 13 percent would still be valuable (i.e. sufficient to detect odds ratios of around 1.5 for an outcome with 1.5 percent prevalence and an exposure with 20 percent prevalence). At submission of this registration, our target sample size is 200,000 participants (80,000 children, 80,000 primary parents and 40,000 second parents). This would represent a 53 percent uptake from our potential denominator of all 150,000 babies born over a 24-month period and their primary parent, and half that for their secondary parent.

Study Design

Study Type:

Observational

Anticipated Enrollment :

200000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Generation Victoria Cohort 2020s. A Longitudinal Birth Cohort of Babies Born in Victoria and Their Parents

Actual Study Start Date :

Oct 4, 2021

Anticipated Primary Completion Date :

Oct 1, 2033

Anticipated Study Completion Date :

Oct 1, 2033

Outcome Measures

Primary Outcome Measures

Number of parents and children enrolled in the GenV Cohort 2020s [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 complete data collection at each wave [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 successful data linkage at each wave [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 [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)

Secondary Outcome Measures

Number of applications to access and analyse GenV end-user datasets [Point of consent until study completion (up to 10 years)]
Assessed by analysis of the GenV data access registry
Number of collaborative observational research studies supported [Point of consent until study completion (up to 10 years)]
Assessed by analysis of GenV Integrated Studies Register
Number of collaborative interventional research studies supported [Point of consent until study completion (up to 10 years)]
Assessed by analysis of GenV Integrated Studies Register
Number of participants involved in concurrent observational research studies embedded within or alongside GenV [Point of consent until study completion (up to 10 years)]
Assessed by analysis of shared study participant relationship management system data
Number of participants involved in concurrent interventional research studies embedded within or alongside GenV [Point of consent until study completion (up to 10 years)]
Assessed by analysis of shared study participant relationship management system data

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria (Children):

Birth date between 4th October 2021 and 3rd October 2023
Live at the time of recruitment
Residing in Victoria at the time of recruitment
Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the child's behalf, who provides a signed and dated informed consent form (e.g. a parent/guardian)

Inclusion Criteria (Adults):

Be a parent or guardian of a child who meets the eligibility criteria above
Provide a signed and dated informed consent form or have a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.

Exclusion criteria:

Babies who are deceased at the time of recruitment (i.e. still born or died after birth) and their parents/guardians
Families unable to provide informed consent in any of the languages available