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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05394363
Registration number
NCT05394363
Ethics application status
Date submitted
23/05/2022
Date registered
27/05/2022
Date last updated
15/06/2023
Titles & IDs
Public title
Generation Victoria Cohort 2020s: A Statewide Longitudinal Cohort Study of Victorian Children and Their Parents
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Scientific title
Generation Victoria Cohort 2020s. A Statewide Longitudinal Cohort of Victorian Children and Their Parents
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Secondary ID [1]
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U1111-1269-3107
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Universal Trial Number (UTN)
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Trial acronym
GenV
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Mental Health
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Child Wellbeing
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Infant Health
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Child Health
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Reproductive Health
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Healthy Aging
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Health Equity
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Quality of Life
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Social Determinants of Health
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Environmental Exposure
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Genetics
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Cognition
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Learning
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Child Development
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Congenital Abnormalities
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Disability
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Injuries
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Communicable Diseases
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Noncommunicable Diseases
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Physical Fitness
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Diet
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Obesity
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Allergy and Immunology
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Inflammation
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Intergenerational Relations
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Condition category
Condition code
Infection
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0
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Studies of infection and infectious agents
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Infection
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0
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0
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Other infectious diseases
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Infection
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0
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Sexually transmitted infections
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Human Genetics and Inherited Disorders
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0
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0
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Other human genetics and inherited disorders
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Reproductive Health and Childbirth
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Fetal medicine and complications of pregnancy
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Public Health
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0
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Other public health
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of parents and children enrolled in the GenV Cohort 2020s
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Assessment method [1]
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Assessed by analysis of records in the study-specific Participant Relationship Management System (PRMS)
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Timepoint [1]
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Point of consent until study completion (up to 10 years)
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Primary outcome [2]
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Number of participants with complete data collection at each wave
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Assessment method [2]
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Assessed by analysis of records in the study-specific Participant Relationship Management System (PRMS), e-Consent platform and GenV data repository
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Timepoint [2]
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Point of consent until study completion (up to 10 years)
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Primary outcome [3]
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Number of participants with successful data linkage at each wave
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Assessment method [3]
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Assessed by analysis of records in the study-specific Participant Relationship Management System (PRMS), e-Consent platform and GenV data repository
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Timepoint [3]
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Point of consent until study completion (up to 10 years)
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Primary outcome [4]
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Number of participants with the targeted biosamples received at each wave
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Assessment method [4]
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Assessed by analysis of records in the study-specific Participant Relationship Management System (PRMS), e-Consent platform and GenV Laboratory Information Management System (LIMS)
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Timepoint [4]
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Point of consent until study completion (up to 10 years)
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Secondary outcome [1]
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Number of applications to access and analyse GenV end-user datasets
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Assessment method [1]
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Assessed by analysis of the GenV data access registry
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Timepoint [1]
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Point of consent until study completion (up to 10 years)
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Secondary outcome [2]
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Number of collaborative observational research studies supported
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Assessment method [2]
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Assessed by analysis of GenV Integrated Studies Register
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Timepoint [2]
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Point of consent until study completion (up to 10 years)
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Secondary outcome [3]
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Number of collaborative interventional research studies supported
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Assessment method [3]
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Assessed by analysis of GenV Integrated Studies Register
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Timepoint [3]
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Point of consent until study completion (up to 10 years)
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Secondary outcome [4]
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Number of participants involved in concurrent observational research studies embedded within or alongside GenV
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Assessment method [4]
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Assessed by analysis of shared study participant relationship management system data
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Timepoint [4]
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Point of consent until study completion (up to 10 years)
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Secondary outcome [5]
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Number of participants involved in concurrent interventional research studies embedded within or alongside GenV
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Assessment method [5]
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Assessed by analysis of shared study participant relationship management system data
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Timepoint [5]
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Point of consent until study completion (up to 10 years)
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Eligibility
Key inclusion criteria
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.
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Minimum age
1
Day
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
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
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
4/10/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/10/2033
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Actual
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Sample size
Target
200000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Murdoch Children's Research Institute - Parkville
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Recruitment postcode(s) [1]
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3052 - Parkville
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Funding & Sponsors
Primary sponsor type
Other
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Name
Murdoch Childrens Research Institute
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Other
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The Paul Ramsay Foundation
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Other
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Name [2]
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Royal Children's Hospital
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Victoria State Government
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Royal Children's Hospital Foundation
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University of Melbourne
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National Health and Medical Research Council, Australia
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Medical Research Future Fund
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Other
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Angliss Health Service
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Bairnsdale Regional Health Service
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Grampians Health - Ballarat Base Hospital
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Bass Coast Regional Health
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Other
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The Bays Private Hospital
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Benalla & District Memorial Hospital
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Bendigo Hospital
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Other
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Box Hill Hospital
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Other
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Name [16]
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Cabrini Private Hospital
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Other
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Casey Hospital
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Other
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Castlemaine Hospital
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Other
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Name [19]
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Central Gippsland Health Service
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Other
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Colac Area Health
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Dandenong Hospital
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Other
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Bacchus Marsh - Western Health (formerly Djerriwarrh Health Service)
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Other
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East Grampians Health Service
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Other
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Name [24]
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Echuca Regional Health
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Other
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Name [25]
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Epworth Freemason's Private Hospital
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Other
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Name [26]
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Frances Perry Private Hospital
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Other
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Name [27]
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Peninsula Health
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Other collaborator category [28]
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Other
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Name [28]
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Epworth Geelong
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Other collaborator category [29]
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Other
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Name [29]
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Geelong University Hospital
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Other
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Goulburn Valley Health
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Other collaborator category [31]
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Other
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Name [31]
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Hamilton Base Hospital
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Other
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Name [32]
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Jessie McPherson Private Hospital
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Address [32]
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Other collaborator category [33]
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Other
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Name [33]
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Joan Kirner Women's and Children's Hospital
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Address [33]
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Other
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Name [34]
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The Kilmore & District Hospital
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Other
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Latrobe Regional Hospital
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Other
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Leongatha Memorial Hospital
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Other
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Name [37]
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Mansfield District Hospital
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Other
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Name [38]
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Maryborough District Health Service
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Address [38]
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Other
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Name [39]
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Mercy Hospital for Women
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Other
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Name [40]
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Mercy Werribee Public Hospital
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Other
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Mildura Base Hospital
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Mitcham Private Hospital
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Other
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Name [43]
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Monash Medical Centre
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Other
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Name [44]
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Northeast Health Wangaratta
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The Northern Hospital
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Northpark Private Hospital
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Peninsula Private Hospital
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Royal Women's Hospital
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Sandringham & District Memorial Hospital
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South Gippsland Hospital
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South West Healthcare Camperdown
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South West Healthcare Warnambool
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St John of God Hospital Ballarat
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St John of God Hospital Bendigo
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St John of God Hospital Berwick
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St John of God Hospital Geelong
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St Vincents Private Hospital
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Swan Hill District Hospital
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Waverley Private Hospital
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West Gippsland Healthcare Group
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Grampians Health - Horsham (formerly Wimmera Health Care Group)
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Albury Wodonga Health
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Yarrawonga District Health Service
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Portland District Health
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Ethics approval
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Summary
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 an Advance
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 Advance Cohort have ongoing and full participation
in GenV for their lifetime unless they withdraw but may have less complete data and
biosamples.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05394363
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Melissa Wake, MBChB, FRACP, FAHMS, MD
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Address
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Murdoch Children's Research Institute
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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GenV Cohort Coordinator
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Address
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Phone
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+61 1800 436 888
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Fax
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05394363
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