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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05394363




Registration number
NCT05394363
Ethics application status
Date submitted
23/05/2022
Date registered
27/05/2022

Titles & IDs
Public title
Generation Victoria Cohort 2020s: A Statewide Longitudinal Cohort Study of Victorian Children and Their Parents
Scientific title
Generation Victoria Cohort 2020s. A Statewide Longitudinal Cohort of Victorian Children and Their Parents
Secondary ID [1] 0 0
U1111-1269-3107
Universal Trial Number (UTN)
Trial acronym
GenV
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Health 0 0
Child Wellbeing 0 0
Infant Health 0 0
Child Health 0 0
Reproductive Health 0 0
Healthy Aging 0 0
Health Equity 0 0
Quality of Life 0 0
Social Determinants of Health 0 0
Environmental Exposure 0 0
Genetics 0 0
Cognition 0 0
Learning 0 0
Child Development 0 0
Congenital Abnormalities 0 0
Disability 0 0
Injuries 0 0
Communicable Diseases 0 0
Noncommunicable Diseases 0 0
Physical Fitness 0 0
Diet 0 0
Obesity 0 0
Allergy and Immunology 0 0
Inflammation 0 0
Intergenerational Relations 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy
Public Health 0 0 0 0
Other public health

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of parents and children enrolled in the GenV Cohort 2020s
Timepoint [1] 0 0
Point of consent until study completion (up to 10 years)
Primary outcome [2] 0 0
Number of participants with complete data collection at each wave
Timepoint [2] 0 0
Point of consent until study completion (up to 10 years)
Primary outcome [3] 0 0
Number of participants with successful data linkage at each wave
Timepoint [3] 0 0
Point of consent until study completion (up to 10 years)
Primary outcome [4] 0 0
Number of participants with the targeted biosamples received at each wave
Timepoint [4] 0 0
Point of consent until study completion (up to 10 years)
Secondary outcome [1] 0 0
Number of applications to access and analyse GenV end-user datasets
Timepoint [1] 0 0
Point of consent until study completion (up to 10 years)
Secondary outcome [2] 0 0
Number of collaborative observational research studies supported
Timepoint [2] 0 0
Point of consent until study completion (up to 10 years)
Secondary outcome [3] 0 0
Number of collaborative interventional research studies supported
Timepoint [3] 0 0
Point of consent until study completion (up to 10 years)
Secondary outcome [4] 0 0
Number of participants involved in concurrent observational research studies embedded within or alongside GenV
Timepoint [4] 0 0
Point of consent until study completion (up to 10 years)
Secondary outcome [5] 0 0
Number of participants involved in concurrent interventional research studies embedded within or alongside GenV
Timepoint [5] 0 0
Point of consent until study completion (up to 10 years)

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.
Minimum age
1 Day
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2033
Actual
Sample size
Target
200000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Murdoch Children's Research Institute - Parkville
Recruitment postcode(s) [1] 0 0
3052 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Paul Ramsay Foundation
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Royal Children's Hospital
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Victoria State Government
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Royal Children's Hospital Foundation
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
University of Melbourne
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
National Health and Medical Research Council, Australia
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Medical Research Future Fund
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Angliss Health Service
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
Bairnsdale Regional Health Service
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
Grampians Health - Ballarat Base Hospital
Address [10] 0 0
Country [10] 0 0
Other collaborator category [11] 0 0
Other
Name [11] 0 0
Bass Coast Regional Health
Address [11] 0 0
Country [11] 0 0
Other collaborator category [12] 0 0
Other
Name [12] 0 0
The Bays Private Hospital
Address [12] 0 0
Country [12] 0 0
Other collaborator category [13] 0 0
Other
Name [13] 0 0
Benalla & District Memorial Hospital
Address [13] 0 0
Country [13] 0 0
Other collaborator category [14] 0 0
Other
Name [14] 0 0
Bendigo Hospital
Address [14] 0 0
Country [14] 0 0
Other collaborator category [15] 0 0
Other
Name [15] 0 0
Box Hill Hospital
Address [15] 0 0
Country [15] 0 0
Other collaborator category [16] 0 0
Other
Name [16] 0 0
Cabrini Private Hospital
Address [16] 0 0
Country [16] 0 0
Other collaborator category [17] 0 0
Other
Name [17] 0 0
Casey Hospital
Address [17] 0 0
Country [17] 0 0
Other collaborator category [18] 0 0
Other
Name [18] 0 0
Castlemaine Hospital
Address [18] 0 0
Country [18] 0 0
Other collaborator category [19] 0 0
Other
Name [19] 0 0
Central Gippsland Health Service
Address [19] 0 0
Country [19] 0 0
Other collaborator category [20] 0 0
Other
Name [20] 0 0
Colac Area Health
Address [20] 0 0
Country [20] 0 0
Other collaborator category [21] 0 0
Other
Name [21] 0 0
Dandenong Hospital
Address [21] 0 0
Country [21] 0 0
Other collaborator category [22] 0 0
Other
Name [22] 0 0
Bacchus Marsh - Western Health (formerly Djerriwarrh Health Service)
Address [22] 0 0
Country [22] 0 0
Other collaborator category [23] 0 0
Other
Name [23] 0 0
East Grampians Health Service
Address [23] 0 0
Country [23] 0 0
Other collaborator category [24] 0 0
Other
Name [24] 0 0
Echuca Regional Health
Address [24] 0 0
Country [24] 0 0
Other collaborator category [25] 0 0
Other
Name [25] 0 0
Epworth Freemason's Private Hospital
Address [25] 0 0
Country [25] 0 0
Other collaborator category [26] 0 0
Other
Name [26] 0 0
Frances Perry Private Hospital
Address [26] 0 0
Country [26] 0 0
Other collaborator category [27] 0 0
Government body
Name [27] 0 0
Peninsula Health
Address [27] 0 0
Country [27] 0 0
Other collaborator category [28] 0 0
Other
Name [28] 0 0
Epworth Geelong
Address [28] 0 0
Country [28] 0 0
Other collaborator category [29] 0 0
Other
Name [29] 0 0
Geelong University Hospital
Address [29] 0 0
Country [29] 0 0
Other collaborator category [30] 0 0
Other
Name [30] 0 0
Goulburn Valley Health
Address [30] 0 0
Country [30] 0 0
Other collaborator category [31] 0 0
Other
Name [31] 0 0
Hamilton Base Hospital
Address [31] 0 0
Country [31] 0 0
Other collaborator category [32] 0 0
Other
Name [32] 0 0
Jessie McPherson Private Hospital
Address [32] 0 0
Country [32] 0 0
Other collaborator category [33] 0 0
Other
Name [33] 0 0
Joan Kirner Women's and Children's Hospital
Address [33] 0 0
Country [33] 0 0
Other collaborator category [34] 0 0
Other
Name [34] 0 0
The Kilmore & District Hospital
Address [34] 0 0
Country [34] 0 0
Other collaborator category [35] 0 0
Other
Name [35] 0 0
Latrobe Regional Hospital
Address [35] 0 0
Country [35] 0 0
Other collaborator category [36] 0 0
Other
Name [36] 0 0
Leongatha Memorial Hospital
Address [36] 0 0
Country [36] 0 0
Other collaborator category [37] 0 0
Other
Name [37] 0 0
Mansfield District Hospital
Address [37] 0 0
Country [37] 0 0
Other collaborator category [38] 0 0
Other
Name [38] 0 0
Maryborough District Health Service
Address [38] 0 0
Country [38] 0 0
Other collaborator category [39] 0 0
Other
Name [39] 0 0
Mercy Hospital for Women
Address [39] 0 0
Country [39] 0 0
Other collaborator category [40] 0 0
Other
Name [40] 0 0
Mercy Werribee Public Hospital
Address [40] 0 0
Country [40] 0 0
Other collaborator category [41] 0 0
Other
Name [41] 0 0
Mildura Base Hospital
Address [41] 0 0
Country [41] 0 0
Other collaborator category [42] 0 0
Other
Name [42] 0 0
Mitcham Private Hospital
Address [42] 0 0
Country [42] 0 0
Other collaborator category [43] 0 0
Other
Name [43] 0 0
Monash Medical Centre
Address [43] 0 0
Country [43] 0 0
Other collaborator category [44] 0 0
Other
Name [44] 0 0
Northeast Health Wangaratta
Address [44] 0 0
Country [44] 0 0
Other collaborator category [45] 0 0
Other
Name [45] 0 0
The Northern Hospital
Address [45] 0 0
Country [45] 0 0
Other collaborator category [46] 0 0
Other
Name [46] 0 0
Northpark Private Hospital
Address [46] 0 0
Country [46] 0 0
Other collaborator category [47] 0 0
Other
Name [47] 0 0
Peninsula Private Hospital
Address [47] 0 0
Country [47] 0 0
Other collaborator category [48] 0 0
Other
Name [48] 0 0
Royal Women's Hospital
Address [48] 0 0
Country [48] 0 0
Other collaborator category [49] 0 0
Other
Name [49] 0 0
Sandringham & District Memorial Hospital
Address [49] 0 0
Country [49] 0 0
Other collaborator category [50] 0 0
Other
Name [50] 0 0
South Gippsland Hospital
Address [50] 0 0
Country [50] 0 0
Other collaborator category [51] 0 0
Other
Name [51] 0 0
South West Healthcare Camperdown
Address [51] 0 0
Country [51] 0 0
Other collaborator category [52] 0 0
Other
Name [52] 0 0
South West Healthcare Warnambool
Address [52] 0 0
Country [52] 0 0
Other collaborator category [53] 0 0
Other
Name [53] 0 0
St John of God Hospital Ballarat
Address [53] 0 0
Country [53] 0 0
Other collaborator category [54] 0 0
Other
Name [54] 0 0
St John of God Hospital Bendigo
Address [54] 0 0
Country [54] 0 0
Other collaborator category [55] 0 0
Other
Name [55] 0 0
St John of God Hospital Berwick
Address [55] 0 0
Country [55] 0 0
Other collaborator category [56] 0 0
Other
Name [56] 0 0
St John of God Hospital Geelong
Address [56] 0 0
Country [56] 0 0
Other collaborator category [57] 0 0
Other
Name [57] 0 0
St Vincents Private Hospital
Address [57] 0 0
Country [57] 0 0
Other collaborator category [58] 0 0
Other
Name [58] 0 0
Swan Hill District Hospital
Address [58] 0 0
Country [58] 0 0
Other collaborator category [59] 0 0
Other
Name [59] 0 0
Waverley Private Hospital
Address [59] 0 0
Country [59] 0 0
Other collaborator category [60] 0 0
Other
Name [60] 0 0
West Gippsland Healthcare Group
Address [60] 0 0
Country [60] 0 0
Other collaborator category [61] 0 0
Other
Name [61] 0 0
Grampians Health - Horsham (formerly Wimmera Health Care Group)
Address [61] 0 0
Country [61] 0 0
Other collaborator category [62] 0 0
Other
Name [62] 0 0
Albury Wodonga Health
Address [62] 0 0
Country [62] 0 0
Other collaborator category [63] 0 0
Other
Name [63] 0 0
Yarrawonga District Health Service
Address [63] 0 0
Country [63] 0 0
Other collaborator category [64] 0 0
Other
Name [64] 0 0
Portland District Health
Address [64] 0 0
Country [64] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Melissa Wake, MBChB, FRACP, FAHMS, MD
Address 0 0
Murdoch Children's Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
GenV Cohort Coordinator
Address 0 0
Country 0 0
Phone 0 0
+61 1800 436 888
Fax 0 0
Email 0 0
genv@mcri.edu.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF)
When will data be available (start and end dates)?
The first wave of data is expected to become available after the full GenV Cohort 2020s recruitment is complete (ie after October 2023 + allowing time for data preparation). Subsequent releases will follow completed waves of data collection, with each age-specific wave expected to be in the field for around 3 years (Vanguard + Cohort 2020s), and to then be available indefinitely. Limited data may be made available to some collaborators prior to this, for example to support specific operations of integrated studies.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.genv.org.au/for-researchers/enquire-about-collaborating-with-genv/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05394363