NCT05394363

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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150,000

participants targeted

Target at P75+ for all trials

Timeline
90mo left

Started Oct 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
Oct 2021Oct 2033

Study Start

First participant enrolled

October 4, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 27, 2022

Completed
11.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2033

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2033

Last Updated

August 3, 2025

Status Verified

July 1, 2025

Enrollment Period

12 years

First QC Date

May 23, 2022

Last Update Submit

July 30, 2025

Conditions

Mental HealthChild WellbeingInfant HealthChild HealthReproductive HealthHealthy AgingHealth EquityQuality of LifeSocial Determinants of HealthEnvironmental ExposureGeneticsCognitionLearningChild DevelopmentCongenital AbnormalitiesDisabilityInjuriesCommunicable DiseasesNoncommunicable DiseasesPhysical FitnessDietObesityAllergy and ImmunologyInflammationIntergenerational Relations

Keywords

Generation VictoriaGenVCohort StudiesData CollectionData LinkageChild HealthMidlife HealthChildrenInfantsFamilyParentsMothersFathersLife course perspectivePopulation HealthLongitudinal StudiesGenetics, populationDemographyEpidemiologyHealth DisparityMinority HealthVulnerable PopulationsHealth EquityClinical TrialRandomized Controlled TrialPragmatic Clinical TrialHealth Services ResearchEconomic ModelsValue of LifeGeographic Information SystemsSocial Determinants of HealthClimate ChangeBuilt Environment

Outcome Measures

Primary Outcomes (4)

  • Number of parents and children enrolled in the GenV Cohort 2020s

    Assessed by analysis of records in the study-specific Participant Relationship Management System (PRMS)

    Point of consent until study completion (up to 10 years)

  • Number of participants with complete data collection at each wave

    Assessed by analysis of records in the study-specific Participant Relationship Management System (PRMS), e-Consent platform and GenV data repository

    Point of consent until study completion (up to 10 years)

  • Number of participants with successful data linkage at each wave

    Assessed by analysis of records in the study-specific Participant Relationship Management System (PRMS), e-Consent platform and GenV data repository

    Point of consent until study completion (up to 10 years)

  • Number of participants with the targeted biosamples received at each wave

    Assessed by analysis of records in the study-specific Participant Relationship Management System (PRMS), e-Consent platform and GenV Laboratory Information Management System (LIMS)

    Point of consent until study completion (up to 10 years)

Secondary Outcomes (5)

  • Number of applications to access and analyse GenV end-user datasets

    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 participants involved in concurrent interventional research studies embedded within or alongside GenV

    Point of consent until study completion (up to 10 years)

Eligibility Criteria

Age1 Day+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All children living in the state of Victoria, Australia, born between 4th October 2021 and 3rd October 2023, and their parents/guardians.

You may qualify if:

  • 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)
  • 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.

You may not qualify if:

  • Children 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Murdoch Children's Research Institute

Parkville, Victoria, 3052, Australia

RECRUITING

Related Publications (1)

  • Hughes EK, Siero W, Gulenc A, Clifford SA, Frugier T, Hall SM, Mohal J, North K, Zaritski N, Goldfeld S, Saffery R, Wake M. Generation Victoria (GenV): protocol for a longitudinal birth cohort of Victorian children and their parents. BMC Public Health. 2025 Jan 3;25(1):20. doi: 10.1186/s12889-024-21108-1.

    PMID: 39754130DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Universal residual biosamples from those already collected and stored by pathology providers: * Maternal Serum Screen (MSS) or Non-invasive Prenatal Test (NIPT) * Newborn Screening (NBS, Guthrie) cards * Prenatal biosamples from routine 1st, 2nd and 3rd trimester clinical pathology testing (eg. serum, whole blood and plasma throughout pregnancy, third trimester group B strep (GBS) vaginal/anal swab). New biosamples collected directly by GenV: * Saliva (child and parents) * Child stool * Breast milk

MeSH Terms

Conditions

Psychological Well-BeingCongenital AbnormalitiesWounds and InjuriesCommunicable DiseasesNoncommunicable DiseasesObesityHypersensitivityInflammation

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsImmune System Diseases

Study Officials

  • Melissa Wake, MBChB, FRACP, FAHMS, MD

    Murdoch Childrens Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

GenV Cohort Coordinator

CONTACT

+61 1800 436 888genv@mcri.edu.au

GenV Cohort Design Lead

CONTACT

+61 3 9345 4738libby.hughes@mcri.edu.au

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2022

First Posted

May 27, 2022

Study Start

October 4, 2021

Primary Completion (Estimated)

October 1, 2033

Study Completion (Estimated)

October 1, 2033

Last Updated

August 3, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

GenV is designed as an Open Science resource. Privacy-protected child and parent research data will be made available spanning: * Individual physical and mental health, education, social and bioassay data * Neighbourhood data (eg pollution, childcare) Data will in general be made available after completion and data preparation for entire waves of data collection. An access policy is currently under development. GenV's biosamples are small in volume and depletable. Therefore, bioassay requests are most likely to proceed if they: * Are for all participants in GenV (or for the whole subgroup with that biosample) * Would be valued by many researchers * Generate broad, not hypothesis-specific, biodata (eg -omics panels) * Are supported by funding and quality processes.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
The first wave of data is expected to become publicly available in 2026. Subsequent releases will follow completed waves of data collection and are expected to be available indefinitely. Limited data are accessible to some collaborators prior to this, for example to support specific operations of integrated studies.
Access Criteria
Data will be made available to approved end-users for analyses that achieve the aims in the approved proposal. Approval is based on: * The research aims to improve health, development, or wellbeing * The proposed use of the data is covered by ethical approval * GenV assesses the safety and expertise of the applicant and the institution/organisation * Samples/data are used with participant privacy protection in place * Users agree to GenV's conditions of use.
More information

Available IPD Datasets

GenV Protocol paper (open access) Access
Informed Consent Form Access
Generation Victoria (GenV) Cohort 2020s Statement of Intent Access
Generation Victoria (GenV) Cohort 2020s Synopsis Access
Guidance and expressions of interest for enquires and proposals to collaborate with GenV Access
Current GenV collaborations Access
Working Papers relevant to GenV design, data sharing and researchers working with GenV Access
Published Papers relevant to GenV design, data sharing and researchers working with GenV Access

Locations

AU(1)